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INTERNATIONAL ASSOCIATION FOR THE STUDY OF LUNG

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					INTERNATIONAL ASSOCIATION FOR THE STUDY OF LUNG
                    CANCER
               Prospective Mesothelioma Staging Project



                                                        Online Data Management
                                                   System Instruction Manual and
                                                     Forms Completion Guidelines




                                                                     Last revised24APR2012
Contents
INTRODUCTION ........................................................................................................................................................................................................................................ 3
GENERAL eCRF COMPLETION INSTRUCTIONS ....................................................................................................................................................................................... 14
REGISTERING A PATIENT ........................................................................................................................................................................................................................ 15
PATIENT INFORMATION PAGE ............................................................................................................................................................................................................... 17
PATIENT CHARACTERISTICS.................................................................................................................................................................................................................... 18
PRE-TREATMENT/EVALUATIVE LABORATORY VALUES .......................................................................................................................................................................... 23
HOW TO CREATE A SET OF NORMAL LIMITS FOR LABORATORY VALUES.............................................................................................................................................. 25
HOW TO APPLY A SET OF NORMAL LIMITS TO A PATIENT’S LABORATORY VALUES FORM .................................................................................................................. 31
DISEASE DESCRIPTION AT DIAGNOSIS ................................................................................................................................................................................................... 32
PRE-TREATMENT TNM ........................................................................................................................................................................................................................... 35
PRE-TREATMENT ASSESSMENT OF PLEURAL THICKNESS AND PRESENCE OF EFFUSIONS .................................................................................................................... 38
PRE-TREATMENT ASSESSMENT OF DIRECT INVASION........................................................................................................................................................................... 39
PRE-TREATMENT ASSESSMENT OF DIRECT INVASION........................................................................................................................................................................... 40
PRE-TREATMENT ASSESSMENT OF NODAL INVOLVEMENT................................................................................................................................................................... 41
PRE-TREATMENT ASSESSMENT OF DISTANT METASTASIS .................................................................................................................................................................... 42
TREATMENT ........................................................................................................................................................................................................................................... 43
POST-SURGICAL TNM ............................................................................................................................................................................................................................. 46
POST-SURGICAL ASSESSMENT OF DIRECT INVASION ............................................................................................................................................................................ 48
POST-SURGICAL ASSESSMENT OF NODAL INVOLVEMENT .................................................................................................................................................................... 51
POST-SURGICAL ASSESSMENT OF DISTANT METASTASIS ...................................................................................................................................................................... 53
FOLLOW-UP............................................................................................................................................................................................................................................ 54
APPENDIX A – POTENTIAL SOURCES OF ASBESTOS EXPOSURE ............................................................................................................................................................. 55
APPENDIX B – COMORBIDITY ITEMS...................................................................................................................................................................................................... 56
APPENDIX C – MEASUREMENT OF MAXIMAL PLEURAL THICKNESS ...................................................................................................................................................... 57



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                                                            INTRODUCTION


The IASLC Prospective Mesothelioma Staging Project uses a web based data entry system for data submissions through the data management
services of Cancer Research And Biostatistics (CRAB).

At your request, you will be sent three forms, including:

   1. Data Use Agreement                                            2. Site Cohort Form




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3. Account Request Form




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                              Page 4
Once you’ve submitted these three forms you will receive an email similar to the one below




The email will include the EDC system URL. You will click on the URL.




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                                           Logon Page: Instructions for First-Time Use




The URL will take you to the Logon Page. Enter your USER ID and click on “Request new password”.




                                                     Click here for first-time use




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                                             Logon Page: Instructions for First-Time Use


     Next you’ll see:




1. Enter your User ID at the first prompt.

2. Enter your email address at the next prompt.

3. Click the Submit button.




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                                           Logon Page: Instructions for First-Time Use




•   You will be asked to select and answer a secret question.
•   Click Submit.
•   If the User ID or email address do not match our data base records you will see the error message below.




    Click the “Contact Us’ link at the top of the page to request help.


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                                             Logon Page: Instructions for First-Time Use


If the User ID and email address are correct you will receive a message as shown below.




The email showing your temporary password will look like this:




Copy the temporary password and return to the logon page.


                                                                                           18APR2012
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                        Logon Page: Instructions for First-Time Use




                                                                      5. Enter your User ID and temporary




6. Then click “Logon”




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                                            Logon Page: Instructions for First-Time Use


You will be asked to answer your selected secret question:




After correctly answering the secret question, you will be shown the page below. Enter your temporary password under the User ID then
create your personal, durable password.




Click the “set password” button.
                                                                                                                            18APR2012
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                                                     Logon Page – Lockouts
In the case of lockouts, five unsuccessful attempts or forgotten passwords, you may regain access to the system by resetting your
password.

The procedure to reset your password is the same as the procedure to set your password for first-time use.




                                                         Questions
If you have any questions regarding the use of this system, including any questions about the data forms, please email us at:

WebHelpIASLC@crab.org. Please indicate “meso” in the email subject line.

Thank you!




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All study case report forms will be accessed through the study website at: https://prodc.crab.org/IASC_MESO/Login.aspx




                                                         User interface components
•   The Logon page allows you to log on.
           ‒ Once you are logged on you will see the Welcome page which will indicate your permissions. From the Welcome page you will have
              access to several tabs:




•   The Patients tab allows you to register patients and view the patients associated with your location in several formats. After selecting a format,
    click on the Patient ID and you will have hyperlinks to the electronic case reports forms (eCRFs).

•   The Labs tab allows you to “Register” labs or to view the list of labs you have previously registered. Registering a lab allows you to retrieve the
    stored upper and lower limits of normal for that lab. This saves time when entering individual patient lab eCRFS.

•   The Reports tab gives you access to the IASLC MPM Staging Accrual Report.

•   The Support tab includes the Database Export Utility (exports data to Excel), the Data Dictionary and the User Instructions (this manual).

•   The Resources tab includes the Instruction Manual (this document), the Study Protocol, the Study Protocol Appendix, Account Request Forms,
    and Create New Password Instructions.

For questions and assistance using the site, please contact: WebHelpIASLC@crab.org

After data entry via the web application by the site coordinators, the data is entered into the Oracle™ data base. The staff at the institution
may recall the data for viewing and amend entries

                                                                                                                                              18APR2012
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                                            GENERAL eCRF COMPLETION INSTRUCTIONS
•   Complete all eCRFs applicable to each patient
•   Complete all applicable fields on each eCRF
•   Complete eCRF as soon as information is available
•   Some eCRF fields have a symbol. Click on the symbol to view additional information explaining the field
•   Date format is dd-mmm-yyyy, where mmm is the English three-character abbreviation for the month
•   Some fields are conditional. That is, the field will be “greyed-out” until a previous question is answered. For example: Unless you indicate
    the patient has prior asbestos exposure, the sources of exposure remain greyed-out.
•   All forms must be submitted by selecting the “submit” button at the bottom of the page in order for the data to be copied from this web-
    based data entry application to the actual Oracle™ data base.
•   As a part of form submission, the system will check the data for consistency and completeness. Any resulting error messages will be posted
    at the top of the page. There are two kinds of error messages: red-light and yellow-light messages.

           Red-light messages indicate definite errors which must be resolved before completing the submission. If a red-light error message is
           present, the form data will not be copied to the study data base.
           Example:

               The patient birth date cannot be after today’s date.

           Yellow-light messages indicate possible errors in the data which should be reviewed before completing the submission.
           Example:

               Final surgical procedure is ' Exploration only (no resection)' but diaphragm was resected and/or reconstructed. This combination
               is unexpected. Please confirm these data.




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                                                            REGISTERING A PATIENT
The permission to register new patients to the system is granted to specific classes of users as specified in the Account Request Form. If Register New Patients
appears as an option in the drop-down menu under the Patients tab, you may register a new patient to the system by following the instructions on this page.




                                                                                                        From the Patients tab, select
                                                                                                        “Register New Patient”




                                               Select the appropriate institution from the drop-down list provided.

                                           Enter a text string of up to 15 characters as the Patient Code. The Patient
                                           Code field is provided so that you may assign a reference number to the
                                           patient for your convenience. The patient code must be unique. Do not
                                           assign the same patient code to more than one patient.




                                        On this page, as with all data entry screens, select “Submit” to commit this
                                        change to the study data base.

                                        Alternatively, select “Cancel” to abort the registration.




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                                                                         REGISTERING A PATIENT

When you have successfully submitted the registration form, the system will respond with a Confirmation of Submission Page as follows.

                                                                                     **Quick Tip: The system is searchable via Patient Code or Patient ID. To navigate to an individual
                                                                                     patient using either Patient Code or Patient ID, select “Go to Patient” under the Patients tab.




                                          At submission of the registration form, the system will assign a nine-digit Patient ID to the patient.




                 Select “Return to Patient Info” to continue to the Patient Information page for this patient.
                 The Patient Information page lists all data forms available for an individual patient.                                                               18APR2012
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                                                                    PATIENT INFORMATION PAGE


The Patient Information Page lists all data forms available for a given patient. Immediately following registration, the forms available for entry will include the Patient
Characteristics, Pre-Treatment / Evaluative Laboratory Values, Disease Description at Diagnosis, Treatment, and first Follow-up pages. Click on any of these forms to begin data
entry.




                                    Select “Patient Characteristics” to begin data entry of the Patient Characteristics Page.




Staging-related forms will not appear in this list until the Treatment page has been submitted. The reason is that the treatment modality, i.e. whether or not surgery was part of
the primary intervention, determines whether there will be one set of TNM or two sets of TNM (pre-treatment and post-surgical).




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                                                                     PATIENT CHARACTERISTICS




                                                                               Sites may elect to provide only year of birth or provide the age at
                                                                               diagnosis (located on the Disease Description at Diagnosis eCRF) in
                                                                               lieu of birth year if this is a requirement for release of the data by
                                                                               the local ethics review board. Substituting age at diagnosis for
                                                                               birth date or year is not advisable for sites which intend to export
                                                  1-Male                       and analyze their data locally.
                                                  2-Female
                                                  3-No Data                                                                                         0-Fully active
                                                                                                                                                    1-Restricted
                                                                                                                                                    2-No work ambulatory
                                                                                                                                                    3-Limited self-care
                                                                                                                                                    4-Completely disabled
                                                                                                                                                    5-Unknown

                                         1-Asian
                                         2-Black or African America
                                         3-White or Caucasian
                                         4-America Indian/Alaskan Native/Pacific Islander
                                         5-Other /Mixed/Uncertain


Note: The reason that hispanic or latino origin does not appear in the drop-down menu is that these terms describe ethnicity rather than race.




                                                                                                                                                                      18APR2012
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          PATIENT CHARACTERISTICS




1-Never smoked        A former smoker is someone who had smoked 100
2-Former smoker       cigarettes in his or her lifetime but quit smoking prior to
3-Current smoker      the diagnosis of lung cancer.
4-No data

                      A current smoker is someone who has smoked 100
                      cigarettes in his or her lifetime.




                   Pack year describes the number of cigarettes a person has smoked
                   over time. One pack year is defined as 20 manufactured cigarettes
                   (one pack) smoked per day for one year.

                   For example:

                   Subject smoked 1 1/2 packs per day for 30 years. This equals 45
                   pack years.

                   1.5 x 30 = 45




                                                                                       18APR2012
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             PATIENT CHARACTERISTICS




1-Yes
2-Probable
3-No
4-No Data




                                                                                         See section 10.2 of the
                                                                                         protocol for more
                                                                                         information. For your
                                                                                         convenience, the information
                     The source of asbestos exposure will be collected in up to three    from Section 10.2 is also
                     data fields moving from general categories to more detailed         included in this manual as
                     information, organized as outlined in the study protocol.           Appendix A.

                     For example, if “asbestos mining” is the source, you would select
                     “1-Occupational exposure – mining and milling occupations” as
                     the most general category from the initial drop-down menu
                     provided. This choice would trigger the appearance of a second
                     drop-down menu (shown below) from which you would select
                     “mining, asbestos” as the more detailed response regarding the
                     source of exposure.




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    PATIENT CHARACTERISTICS




      1-Erioniote
      2-Fiberglass
      3-Other
      4-No data




Please enter the patient’s age at first probable exposure. If the patient had more
than one type of exposure, enter the age at the earliest exposure. For example, if
the patient had 5 years of fiberglass exposure beginning at age 20 and 30 years of
exposure to asbestos beginning at age 25, enter 20 for age at first exposure.

Enter the cumulative number of years of exposure. For the patient mentioned
above, the number of years of exposure is 35 (adding the fiberglass and asbestos
exposures together).




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                                                                     PATIENT CHARACTERISTICS




See section 10.1 of the Protocol for definitions of Comorbidity
items. We have included section 10.1 in this manual as Appendix B.




                                                                     Use this short-cut button to answer ‘no’ for all of the
                                                                     conditions listed in the box below.

                                                                     Use this short-cut button to indicate there is ‘no data’ for
                                                                     any of the conditions listed in the box below.




                                                                     1-Yes
                                                                     2-No
                                                                     3-No Data




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PRE-TREATMENT/EVALUATIVE LABORATORY VALUES




                                             1-International Standard (SI)
                                             units- When International
                                             Standard (SI) units are selected,
                                             the form will use SI units for each
                                             of the laboratory values below.




                                                                       18APR2012
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PRE-TREATMENT/EVALUATIVE LABORATORY VALUES




                                                      None. To be entered manually


                                             1-Male
                                             2-Female
                                             3-No Data

                                             *A different set of normal limits may
                                             apply to HGB, for example, depending on
                                             male vs. female.




                                                                      18APR2012
                                                                         Page 24
                      PRE-TREATMENT/EVALUATIVE LABORATORY VALUES




If PET was performed but Maximum SUV of Pleura is not available, select “not available” below.

The use of PET as a staging tool should still be documented as appropriate in the “Tests Used to
Determine T, N, and M” section of the Pretreatment TNM page.




                                                          Fill out this field only
                        1-No
                                                          if a Maximum SUV of
                        2-Yes
                                                          Pleura is documented
                        3-No data
                                                          above.
                        *Select Yes if Pleurodesis
                        was performed prior to the
                        PET results documented                     Forced Vital Capacity (FVC) is the forceful expiration of air after a
                        here.                                      full inspiration, measured in liters. FEV1 is the Forced Expiratory
                                                                   Volume in the first second of that forceful exhalation. DLCO, the
                                                                   Diffusing Capacity of the Lung for CO (Carbon Monoxide), is the
                                                                   extent to which oxygen passes from the alveolae into the blood.

                                                                   For each laboratory parameter above, % predicted values are
                                                                   defined as the ratio of the observed value for the individual
                                                                   patient to that for a reference population. The choice of the
                                                                   reference population is at the discretion of the institution.




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HOW TO CREATE A SET OF NORMAL LIMITS FOR LABORATORY VALUES




                                                    From the Labs tab, select
                                                    “Register New Lab”



                                                                                Your location will be shown.




                     Enter the name of the new lab, click “Submit”.




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HOW TO CREATE A SET OF NORMAL LIMITS FOR LABORATORY VALUES




           You will see your new lab listed with your
           existing labs.

           Click the arrow to enter lab information.




                                                             18APR2012
                                                                Page 27
HOW TO CREATE A SET OF NORMAL LIMITS FOR LABORATORY VALUES




                                                    You may now correct the lab name if you
                                                    made a mistake or

                                                    Continue to enter lab information




                                                                                              18APR2012
                                                                                                 Page 28
      HOW TO CREATE A SET OF NORMAL LIMITS FOR LABORATORY VALUES




                                                                   Enter a description for this set




Select units, click “Submit”




                                                                                        18APR2012
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HOW TO CREATE A SET OF NORMAL LIMITS FOR LABORATORY VALUES




               Enter the lower and upper limits of normal
               for each laboratory parameter and click
               “Create Data Set”




                                                             18APR2012
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HOW TO APPLY A SET OF NORMAL LIMITS TO A PATIENT’S LABORATORY VALUES FORM




                                                                                                         1- US standard metric units-
                                                                                                         When US standard metric
                                                                                                         units are selected the form
                                                                                                         will use US standard metric
                                                                                                         units for each of the
                                                                                                         laboratory values below.


                                                                                                         After you’ve selected the type of
                                                                                                         units, you will be able to select from
                                                                                                         previously registered labs.
                                                                                                         Registering labs allows you to pre-fill
                                                                                                         the individual patient’s eCRFs with
                                                                                                         normal values. The following is a
                                                                                                         description of how to register a lab
                                                                                                         and provide normal limits.




     When using a pre-specified set of normal limits, you must check this box indicating that you
     have verified that these are the current limits for the specified lab. **NOTE: If you have
     applied a set of normal limits to a given patient’s laboratory results but do not check this
     box, a red-light error will be triggered. In this case, laboratory data will not be copied to the
     study data base until either 1) the box is checked or 2) “none” is selected as the set of
     normal limits to apply in field #2 above and all limits of normal are entered manually.
                                                                                                                                  18APR2012
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                     DISEASE DESCRIPTION AT DIAGNOSIS




                              1-Symptoms
                              2-Screening
                              3-Incidental
                              4-No data
                                                1-Symptomatic
                                                2-Asymptomatic
                                                3-No data


If presentation is
described as                     1-Yes
symptomatic,                     2-No
these fields will                3-No data
be enabled.




                                                                 18APR2012
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                      DISEASE DESCRIPTION AT DIAGNOSIS




                                         1-Yes
                                         2-No
                                         3-No data




1-Yes
2-No
3-No data


                                                         Note: the date of histologic proof of malignancy will be
                                                         considered the date of pathologic diagnosis except when histology
                                                         was not obtained. In that case, date of cytology will be used.




                                                               1-Thoracentesis
            1-Right                                            2-FNA
            2-Left                                             3-Core biopsy
            3-Bilateral                                        4-Thoracoscopic biopsy
            4-No data                                          5-Surgical
                                                               6-No data

                                                                                                            18APR2012
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                                                            DISEASE DESCRIPTION AT DIAGNOSIS




                                                                                               1-Diffuse malignant mesothelioma: Epithelioid mesothelioma
                                                                                               2-Diffuse malignant mesothelioma: Sarcomatoid mesothelioma
                                                                                               3-Diffuse malignant mesothelioma: Desmoplastic mesothelioma
                                                                                               4-Diffuse malignant mesothelioma: Biphasic mesothelioma
                                                                                               5-Diffuse malignant mesothelioma: NOS
                                                                                               6-Localized malignant mesothelioma: Epithelioid mesothelioma
                                                                                               7-Localized malignant mesothelioma: Sarcomatoid mesothelioma
                                                                                               8-Localized malignant mesothelioma: Desmoplastic mesothelioma
                                                                                               9-Localized malignant mesothelioma: Biphasic mesothelioma
If Histologic Type/Subtype is “malignant mesothelioma, NOS” or          1-Localized            10-Localized malignant mesothelioma: NOS
“Other”, these fields will be enabled.                                  2-Diffuse              11-Well differentiated papillary mesothelioma
                                                                        3-No data              12-Malignant mesothelioma, NOS
                                                                        4-Not Applicable       13-Other
                                                                                               14-No data

                                                                                                   1-Yes
                                                                                                   2-No
                                                                                                   3-No data




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PRE-TREATMENT TNM




                    18APR2012
                       Page 35
PRE-TREATMENT TNM




                    18APR2012
                       Page 36
18APR2012
   Page 37
PRE-TREATMENT ASSESSMENT OF PLEURAL THICKNESS AND PRESENCE OF EFFUSIONS




                         1-Minimal
                         2-Rind-like   1-No
                         3-Nodular     2-Yes, non-calcified
                         4-No data     3-Yes, calcified
                                       4-Yes, calcification not specified
                                       5-No data

                                                                             Please see protocol section 10.3 or
                                                                             Appendix C of this manual for
                                                                             instructions on measuring maximal
                                                                             pleural thickness.

                                             1-None
                                             2-Present, right side
                                             3-Present, left side
                                             4-Present, both sides
                      1-Positive
                                             5-Present, side not specified
                      2-Negative
                                             6-No data
                      3-No data

 1-No
 2-Yes, non-calcified
 3-Yes, calcified
 4-Yes, calcification not specified
                                                                                                             18APR2012
 5-No data
                                                                                                                Page 38
                                        PRE-TREATMENT ASSESSMENT OF DIRECT INVASION




Use this button    Indicate ‘no data’
to answer ‘no’     or unknown to all
to all invasions   invasions
                                                                                                  Unless otherwise specified, choices are:
                                                                                                  1-No
                                                                                                  2-Yes
                                                                                                  3-No data




                                                                                                             1-Single focus
                                                                                                             2-Confluent tumor
                                                                    1-No                                     3-No data
                                                                    2-Pleura and endothoracic fascia only
                                                                    3-Fascia and chest wall muscle
                                                                    4-Fascia, chest wall muscle, and ribs
                                                                    5-Yes, no further data
                                                                    6-No data


                                                                    1-None
                                                                    2-Single focus
                                                                    3-Diffuse or multifocal
                                                                    4-Yes, no further data
                                                                    5-No data




                                                                                                                                     18APR2012
                                                                                                                                        Page 39
                                        PRE-TREATMENT ASSESSMENT OF DIRECT INVASION




                                                                                            Unless otherwise specified, choices are:
                                                                                            1-No
                                                                                            2-Yes
                                                                                            3-No data


Use this button to answer ‘no’ to   Indicate ‘no data’ or unknown to
all questions in this box.          all questions in this box.




                                                                                      1-No
                                                                                      2-Mediastinal fat
                                                                                      3-Mediastinal organs
                                                                                      4-No data
                                                                       1-No
                                                                       2-Possible
                                                                       3-Yes
                                                                       4-No data




                                                                             1-No
                                                                             2-Possible
                                                                             3-Probable
                                                                             4-Definite
                                                                             5-Transmural
                                                                             6-No data




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                                                                                                                                          Page 40
PRE-TREATMENT ASSESSMENT OF NODAL INVOLVEMENT




                                  1-IASLC 2009
                                  2-None
                                  3-No data




    Individual results need not
                                                 “+ = At least one node
         be entered if “not
                                                 examined in this region was
      examined” is checked.
                                                 considered to be metastatic”
                                                 “- = All nodes examined in
                                                 this region were considered
                                                 to be nonmetastatic”
                                                 “ND = No node examination
                                                 done in this region or results
                                                 were equivocal (none
                                                 considered metastatic)”




                                                                              18APR2012
                                                                                 Page 41
PRE-TREATMENT ASSESSMENT OF DISTANT METASTASIS




                    Entered on Pre-Treatment
                    TNM Page




1-Absent                                       1-Yes, resected
2-Single                                       2-Yes, biopsied, positive for malignancy
3-Multiple                                     3- Yes, biopsied, negative for malignancy
4-Present                                      4-No
5-No data                                      5-No data




                                                                                           18APR2012
                                                                                              Page 42
            TREATMENT




                        1-None
                        2-Exploration, no pleurodesis
                        3-Exploration, pleurodesis only
                        4-Partial pleurectomy
1-Yes                   5-Pleurectomy/decortication
2-No                    6-Extended pleurectomy/decortication
3-No data               7-Extrapleural pneumonectomy
                        8-Other
                        9-No data




                                                18APR2012
                                                   Page 43
     TREATMENT




                                                   1-None
                                                   2- Median Sternotomy
                                                   3-Thorocotomy
                                                   4-VATS
                                                   5-No data

                                       1-Yes
                                       2-No
                                       3-No data


                                                   1-None
                                                   2-Segmentectomy
                                                   3-Wedge Resection
                                                   4-Lobectomy
1-R1 (Microscopic residual tumor)
                                                   5-Bilobectomy
2-R2 (Macroscopic residual tumor)
3-No data                                          6-Pneumonectomy
                                                   7-Other
                                                   8-No data
* Please note: R0 (Microscopically complete
resection) is not listed as a choice due to the
view that microscopically complete resection of
MPM is highly unlikely.




                                                                          18APR2012
                                                                             Page 44
                                                                                TREATMENT




                                                                                       1-Surgery
                                                                                       2-Systemic therapy
                                                                                       3-Radiation therapy
                                                                                       4-Radiation and systemic therapy
                                                                                       5-None
                                                                                       6-No data


                                                                                    1-Hemithoracic
                                                                                    2-Prophylactic focal radiotherapy to incisions/tract sites only
                                                                                    3-Mediastinal +/- hilar only
                                                                                    4-Radiotherapy to symptomatic focal lesions * (and none of 1-3 above
                                                                                      applies)– Further explanation is provided at the bottom of this page.
                                                                                    5-No data



                                                                         1-Conventional
                                                                         2-Conformal-3D
                                                       1-Yes             3-IMRT
                                                       2-No              4-Other
                                                       3-No data         5-No data


* Radiotherapy to symptomatic focal lesions includes focal radiotherapy to chest wall, bone, spinal cord, brachial plexus, lymphadenopathy, or other lesion sites where
treatment is given in response to symptomatic local tumor involvement and not as prophylaxis.



                                                                                                                                                                     18APR2012
                                                                                                                                                                        Page 45
           POST-SURGICAL TNM




The data entry system will prompt the user to complete post-surgical
forms only if the ‘final surgical procedure’ is described on the Treatment
form as one of the following choices:
2- Exploration, no pleurodesis (no resection)
3-Exploration, pleurodesis only (no resection)
4-Partial pleurectomy
5-Pleurectomy/decortication
6-Extended pleurectomy/decortication
7-Extrapleural pneumonectomy
8-Other

Post-Surgical forms include:
Post-Surgical TNM
Post-Surgical Assessment of Direct Invasion
Post-Surgical Assessment of Nodal Involvement
Post-Surgical Assessment of Distant Metastasis

Note that findings from any surgery other than pleurodesis alone or a
strictly diagnostic procedure will be recorded on Post-Surgical eCRFs.
Findings from pleurodesis alone or strictly diagnostic procedures will be
recorded on Pre-Treatment eCRFs.




                                                                             18APR2012
                                                                                Page 46
                                 POST-SURGICAL TNM




The system calculates Overall
Stage based the T, N, and M as
entered on above.



                                                     18APR2012
                                                        Page 47
POST-SURGICAL ASSESSMENT OF DIRECT INVASION




                                                                  Unless otherwise specified, choices are:
                                                                  1-No
                                                                  2-Yes
                                                                  3-No data




                   Entered on Post-Surgical
                   TNM Page




                    1-Single focus
                    2-Confluent tumor         1-No
                    3-No data                 2-Pleura and endothoracic fascia only
                                              3-Fascia and chest wall muscle
                                              4-Fascia, chest wall muscle, and ribs
                                              5-Yes, no further data
             1-No
             2-Single focus
             3-Diffuse or multifocal
             4-Yes, no further data
             5-No data


                                                                                                        18APR2012
                                                                                                           Page 48
                                         POST-SURGICAL ASSESSMENT OF DIRECT INVASION




                                                                               Unless otherwise specified, choices are:
                                                                               1-No
                                                                               2-Yes
                                                                               3-No data




Indicate ‘no data’ or unknown to   Indicate ‘no data’ or unknown to
all questions in the box below.    all questions in the box below.




                                                                              1-No
                                                                              2-Mediastinal fat
                                                                              3-Mediastinal organs
                                                                              4-No data


                                                                              1-No
                                                                              2-Yes, non-transmural
                                                                              3-Yes, transmural
                                                                              4-Yes, no further data
                                                                              5-No data




                                                                                                                          18APR2012
                                                                                                                             Page 49
POST-SURGICAL ASSESSMENT OF DIRECT INVASION




                                                1-No
                                                2-Muscle only
                                                3-Muscle plus adjacent peritoneum
                                                4-Muscle plus adjacent peritoneum plus adjacent
                                                  abdominal organ
                                                5-Muscle plus diffuse peritoneal, no ascites
                                                6-Muscle plus diffuse peritoneal with ascites
                                                7-Yes, no further data
                                                8-No data
 1-Yes
 2-No
 3-No data      1-None
                2-Present, right side
                3-Present, left side
                4-Present, both sides
                5-Present, side not specified
                6-No data


             1-Positive
             2-Negative
             3-No data

             1-No
             2-Yes, with positive cytology
             3-Yes, with negative cytology
             4-Yes, without cytology results
             5-No data

                                                                                          18APR2012
                                                                                             Page 50
POST-SURGICAL ASSESSMENT OF NODAL INVOLVEMENT




                Entered on Post-Surgical
                TNM Page




                                                18APR2012
                                                   Page 51
  POST-SURGICAL ASSESSMENT OF NODAL INVOLVEMENT




1-Yes
2-No
3-No data




                                                  18APR2012
                                                     Page 52
POST-SURGICAL ASSESSMENT OF DISTANT METASTASIS




                   Entered on Post-Surgical
                   TNM Page




     1-Absent                                    1-Yes, resected
     2-Single                                    2-Yes, biopsied, positive for malignancy
     3-Multiple                                  3- Yes, biopsied, negative for malignancy
     4-Present                                   4-No
     5-No data                                   5-No data




                            1-No
                            2-Yes
                            3-No data




                                                                               18APR2012
                                                                                  Page 53
               FOLLOW-UP




1-Alive
2-Dead
3-Lost to follow-up
4-No Data




                           18APR2012
                              Page 54
APPENDIX A – POTENTIAL SOURCES OF ASBESTOS EXPOSURE




                                                      18APR2012
                                                         Page 55
APPENDIX B – COMORBIDITY ITEMS




                                 18APR2012
                                    Page 56
APPENDIX C – MEASUREMENT OF MAXIMAL PLEURAL THICKNESS




                                                        18APR2012
                                                           Page 57

				
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