Gynae NSSG performance report for 14Jan2010 by TW4yGYQJ

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									                Gynaecology Clinical Trial Portfolio Performance Report

                               Recruitment into NIHR Portfolio studies only


Yearly Comparison 2001/02 to 2009/10


                                           YCRN           NCRN           YCRN % of           YCRN % of Local Incidence
                                                 a                                                                   b
    Year                                   Total         England          National            (697 ppa NYCRIS 2006)
                                                         TOTAL           Recruitment
    2001-2002                                25            540              4.6%                          3.6%
    2002-2003                                13            489              2.7%                          1.9%
    2003-2004                                32            689              4.6%                          4.6%
    2004-2005                                40            717              5.6%                          5.7%
    2005-2006                                35            514              6.8%                          5.0%
    2006-2007                                38            492              7.7%                          5.5%
    2007-2008                                42            871              4.8%                          6.0%
    2008-2009                                31            893              3.5%                          4.4%
    2009-29/12/2009                          20            602              3.3%                          1.3%
    2009-2010 projected                      27            805              3.3%                          1.7%
a
    - YCRN accrual for year 2001/02- 2007/08 is based on UKCRN accrual database.
     YCRN accrual for year 2008/09 onwards is provided by EDGE portfolio management system.
b
    - NYCRIS Reference Data - Registrations, Deaths, Incidence and Mortality Rates 2006 (www.nycris.org.uk)
Comparison of National Cancer Research Networks
Cancer Research Networks are divided into clusters of similar functioning networks. YCRN is in Cluster E which
includes networks that have a very well established cancer clinical research infrastructure of which the NCRN
funding contributes between 30 and 40% of the overall funding. These networks include tertiary referral
centres/specialist treatment centres.




        2007/08
Research Network            Network      NCRN        Network % of National    Research network     Research network
                             Total       Total           Recruitment          cancer incidence *   % local incidence
Yorkshire                      42         997               4.2%                  1845.5                2.3%
Greater Manchester and
Cheshire
                               87         997               8.7%                  2167.7                4.0%
North London                   58         997               5.8%                   659.3                8.8%
South West London              29         997               2.9%                    793                 3.7%
West Anglia                    10         997               1.0%                  2159.7                0.5%
        * network atlas Gynae NCIN/APHO/UKACR From Cancer e-atlas (www.ncin.org.uk/eatlas) 2008




        2008/09
Research Network            Network      NCRN        Network % of National    Research network     Research network
                             Total       Total           Recruitment          cancer incidence *   % local incidence
Yorkshire                      31        1078               2.9%                  1845.5                1.7%
Greater Manchester and
Cheshire                       80        1078               7.4%                  2167.7                3.7%
North London                   34        1078               3.2%                   659.3                5.2%
South West London              47        1078               4.4%                    793                 5.9%
West Anglia                    5         1078               0.5%                  2159.7                0.2%
        * network atlas Gynae NCIN/APHO/UKACR From Cancer e-atlas (www.ncin.org.uk/eatlas) 2008
Recruitment by Trial by Trust/ Network from April 09 to date (29/12/2009)

                                                                                                                                 Greater
                                                                                                                                               North   South West   West
                                                                                                                   Annual       Manchester
                                                                                                                                              London    London      Anglia
Trial                       Airedale   Bradford      C/H      Harrogate    Leeds      MidYorks    York   Total   (projected)   and Cheshire
CA125 Doubling Time             3                                                                          3         4
CCC-1
(GCIG/JGOG3017)                                                            In Setup                        0         0
                     c
CHORUS (feasibility)                                                          2                            2         3
CHORUS (Main trial -
Phase III)                                            1                    In Setup                0       1         1              4           5
DNA Methylation Study                                                      In Setup                        0         0
GROINSS V-II                                                                  1                            1         1                                                2
ICON6                                                                        12                           12         16             6           8          4
mEOC                                                                       In Setup                        0         0
NEO-ESCAPE                  In Setup                                       In Setup                        0         0
NSECG                       In Setup    In Setup                           In Setup                        0         0                                     43
PARP (BRCA)                                                                   1                            1         1
PORTEC3                                                                    In Setup                        0         0
RT3 VIN                                            In Setup                In Setup                        0         0
           d
UKFOCSS                                                                      27                           27         36            43          131         13        26
Patients recruited              3          0          1           0          16           0        0      20                       NA          NA         NA         NA
Annual (Projected)              4          0          1           0          21           0        0      27

c
    - Accrual fro CHORUS feasibility study will be counted under CHORUS main trial once it is open on site.
d
    - Study highlighted in Green does not count towards NCRN accrual totals.

N.B where a 0 is present trial is open but has not yet recruited this year.
This data is now received direct from your local research teams in real time and it is as accurate as of 29/12/09.

Please note:
    (a) Recruitment for the other 4 networks is provided by UKCRN accrual data while recruitment for YCRN is provided by EDGE system.
    (b) The above portfolio for other networks would not contain trials with 0 recruitment or the ones in set up.
Trials open in other Cluster Networks but not within Yorkshire

                                  Greater Manchester      North      South West      West
Trial
                                     and Cheshire        London       London         Anglia
DCE-MRI *                                 3
NCRN065                                   1                 4             4
NCRN114 *                                                                              3
PRECIOUS *                                9
Cervical screening among
                                                            3             1
Eastern European migrants *


Please see enclosed study details (provided by UKCRN portfolio database) for the above studies.

* Trial not open in other sites.
                                                                                                                User
UK Clinical Research Network : Portfolio Database
                                                                                                               Guide
Welcome to the UK Clinical Research Network Study Portfolio




       NB: The information displayed below does not replace the protocol. The latest protocol version should
       always be consulted before making clinical decisions.



        DCE-MRI                                                          ISRCTN
        Dynamic contrast enhanced MRI measurement of tissue              EudraCT
        perfusion in cancer patients                                     MREC N°          05/Q1406/15
                                                                         UKCRN ID         4771
        Topic                                                            WHO ID
        Cancer
        Portfolio Eligibility
        Funded by UKCRC partner



        Research Summary




        Study Type              Interventional               Current Status        Open
        Design Type             Screening                    Closure Date          01/07/2009
        Disease(s)              Cervix                       Sample Size           100
                                                             Accrual to Date
        Phase                   Pilot/Feasibility                                          30%




        Geographical Scope        Single Centre
        Lead Country              England
        Open to new sites         No




        Main Inclusion Criteria                              Main Exclusion Criteria
        Patient over 18 years Patient receives radical       Patients with: cardiac pacemakers cochlear
        treatment for cervical cancer at Christie            implants interocular foreign bodies MRI
        Hospital Written informed consent                    incompatible factors palliative treatment for
                                                             advanced disease previous adverse reactions to
                                                             MRI contrast agent



        Chief Investigator(s)
        Mr Andrew Jones



        Further details, please contact
Ms Rebecca Elliott


Rebecca.M.Elliott@manchester.ac.uk




Funder(s)            Cancer Research UK

Sponsor(s)           Christie Hospital NHS Foundation Trust




                                                                                    public.ukcrn.org.uk/search
                                           If you experience problems using the application, please click here.
                                                                                                                      User
UK Clinical Research Network : Portfolio Database
                                                                                                                     Guide
Welcome to the UK Clinical Research Network Study Portfolio




       NB: The information displayed below does not replace the protocol. The latest protocol version should
       always be consulted before making clinical decisions.



        NCRN065
        Phase II randomised, double blind, multicentre study to
        assess the efficacy of AZD2281 in the treatment of                     MREC N°
        patients with platinum sensitive serous ovarian cancer
        following treatment with two or more platinum containing               UKCRN ID                   6518
        regimens


        Topic
        Cancer
        Portfolio Eligibility
        UKCRN adopted, commercial study




        Study Type               Interventional                   Current Status                         Open
        Design Type              Treatment
        Disease(s)               Ovary                            Sample Size                            250

        Phase                    II



        Lead Country              England
        Open to new sites         Yes, within lead country only




        Additional Information
        If you are a patient or relative this link will take you to a description of the trial in plain English on
        CancerHelp UK.



        Main Inclusion Criteria                                   Main Exclusion Criteria
        • Female patients with histologically or                  • Previous treatment with PARP inhibitors
        cytologically diagnosed serous ovarian cancer             including AZD2281
        or recurrent serous ovarian cancer.                       • Patients with low grade ovarian carcinoma
        • Patients must have completed at least 2                 • Patients who have had drainage of their
        previous courses of platinum containing                   ascites during the final 2 cycles of their last
        therapy; for the penultimate chemotherapy                 chemotherapy regimen prior to enrolment on
        course prior to enrolment on the study the                the study
        patient must have been platinum sensitive                 • Patients receiving any chemotherapy,
• For the last chemotherapy course prior to         radiotherapy (except for palliative reasons),
enrolment on the study, patients must have          within 2 weeks from the last dose prior to study
demonstrated an objective stable maintained         entry (or a longer period depending on the
response (partial or complete response) and         defined characteristics of the agents used).
this response needs to be maintained until
completion of chemotherapy
• Patients must be treated on the study within
8 wks of completion of their final dose of the
platinum containing regimen.



Chief Investigator(s)
Prof Jonathan Ledermann



Further details, please contact
Ms Esme Remfry


Esme.Remfry@parexel.com




Funder(s)         AstraZeneca UK Ltd

Sponsor(s)        AstraZeneca UK Ltd




                                                                                  public.ukcrn.org.uk/search
                                         If you experience problems using the application, please click here.
                                                                                                                     User
UK Clinical Research Network : Portfolio Database
                                                                                                                    Guide
Welcome to the UK Clinical Research Network Study Portfolio




       NB: The information displayed below does not replace the protocol. The latest protocol version should
       always be consulted before making clinical decisions.



        NCRN114
        A Multicenter Trial to Measure Early Patterns of Change in
        [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed              MREC N°
        Ovarian Cancer Patients.
                                                                           UKCRN ID                  7520

        Topic
        Cancer
        Portfolio Eligibility
        UKCRN adopted, commercial study




        Study Type Observational                              Current Status                         Open
        Design        Validn of investig/therapeutic
        Type          procs                                   Sample Size                            40
        Disease(s)    Ovary

        Phase         I



        Lead Country            England
        Open to new sites       No




        Main Inclusion Criteria                               Main Exclusion Criteria
        1. Patient is female and ≥35 years of age on          1. Patient has a life expectancy of < 6 months.
        the day of signing the informed consent.              2. Patient has had abdominal surgery within 6
        2. Patient has histologically confirmed               weeks of the screening visit.
        epithelial ovarian, primary peritoneal, or            3. Patient has had radiotherapy to the abdomen
        fallopian tube cancer.                                or pelvis within 6 months of the screening visit.
        3. Patient has first or subsequent relapse,           4. Patient has an unresolved bowel obstruction.
        previously confirmed on CT with or without a          5. Patient has poorly controlled diabetes
        rise in CA-125.                                       mellitus with fasting plasma glucose > 150
        4. Patient has had at least one prior platinum-       mg/dL (8.3 mmol/L).
        based treatment for ovarian cancer.                   6. Patient is currently participating or has
        5. Patient has had at least a 6-month                 participated in a study with an investigational
        progression-free interval after prior platinum-       compound or device within 30 days of the start
        based therapy.                                        of treatment.
        6. Patient is scheduled to receive standard of        7. Patient has a history or current evidence of
        care chemotherapy treatment with carboplatin          any condition, therapy, or lab abnormality that
        or cisplatin monotherapy, or two drug                 might confound the results of the study,
        combinations where one is a platinum as               interfere with patient’s participation for the full
        stipulated by their treating physician. Patient       duration of the study, or is not in the best
has no contra-indications for treatment with a        interest of the patient to participate.
platinum-based regimen.                               8. Patient is unlikely to comply with the
7. Patient has a performance status of 0, 1, or       requirements of the trial.
2 on the Eastern Cooperative Oncology Group
(ECOG).

8. Patient must have adequate organ function
as indicated by the following laboratory
values:
System Laboratory Value
Renal
Calculated creatinine clearance† ≥60 mL/min
† Creatinine clearance should be calculated
per institutional standard.

9. Patient is either post-menopausal (free
from menses for >2 years), surgically
sterilized, or willing to use (and/or have their
partner use) 2 acceptable methods of
contraception to prevent pregnancy or agrees
to abstain from heterosexual activity
throughout the study, beginning at Visit 1.
10. Patients of childbearing potential must
demonstrate a urine or serum β-hCG level
consistent with nongravid state at screening.
11. Patient has voluntarily agreed to
participate by giving written informed consent.
12. Patient must be available for periodic
blood sampling, study related assessments
and management at the treating institution for
the duration of the study.



Chief Investigator(s)
Dr James Brenton



Further details, please contact
NCRN Coordinating Centre

UKCRN
15-19 Hyde Terrace
Leeds
West Yorkshire
LS2 9LT
UNITED KINGDOM

enquiries@ncrn.org.uk




Funder(s)          Merck Sharp & Dohme Ltd

Sponsor(s)         Merck Sharp & Dohme Ltd




                                                                                     public.ukcrn.org.uk/search
                                           If you experience problems using the application, please click here.
                                                                                                                User
UK Clinical Research Network : Portfolio Database
                                                                                                               Guide
Welcome to the UK Clinical Research Network Study Portfolio




       NB: The information displayed below does not replace the protocol. The latest protocol version should
       always be consulted before making clinical decisions.



        PRECIOUS                                                         ISRCTN
        Improving the assessment and recording of cancer                 EudraCT
        treatment effects                                                MREC N°          06/Q1405/36
                                                                         UKCRN ID         4772
        Topic                                                            WHO ID
        Cancer
        Portfolio Eligibility
        Funded by UKCRC partner



        Research Summary




        Study Type    Observational                          Current Status     Open
        Design Type Validation of outcome measures           Closure Date       01/06/2012
        Disease(s)    Cervix                                 Sample Size        100
                      Endometrium                            Accrual to Date
                      Prostate                                                                      85%
                      Uterus

        Phase         Pilot/Feasibility



        Geographical Scope       Single Centre
        Lead Country             England
        Open to new sites        No




        Main Inclusion Criteria                              Main Exclusion Criteria
        18 years & over Radical radiotherapy patients        Insufficient understanding of the English
                                                             language because the study relates to the
                                                             development of questionnaires Patients with
                                                             chronic disease who are deemed terminally ill



        Chief Investigator(s)
        Dr Susan Davidson



        Further details, please contact
Ms Rebecca Elliott


Rebecca.M.Elliott@manchester.ac.uk




Funder(s)            Cancer Research UK

Sponsor(s)           Christie Hospital NHS Foundation Trust




                                                                                    public.ukcrn.org.uk/search
                                           If you experience problems using the application, please click here.
                                                                                                                   User
UK Clinical Research Network : Portfolio Database
                                                                                                                  Guide
Welcome to the UK Clinical Research Network Study Portfolio




       NB: The information displayed below does not replace the protocol. The latest protocol version should
       always be consulted before making clinical decisions.



        Cervical screening among Eastern European                           ISRCTN
        migrants                                                            EudraCT
        Understanding cervical screening participation among                MREC N°
        women immigrants from Eastern Europe
                                                                            UKCRN ID                  6068
                                                                            WHO ID
        Topic
        Cancer (co-adopted by PCRN)
        Portfolio Eligibility
        Funded by UKCRC partner



        Research Summary
        The recent rise in migration to the UK from EU accession countries has presented challenges to the
        NHS. Given the demographic profile of the migrant worker population, their healthcare needs are
        relatively low, and their contact with healthcare services tends to be limited. Similarly, their
        likelihood of screening involvement is likely to be reduced. This study, which is a part of a larger
        project, aims to gain insight into perspectives of healthcare professionals on the possible barriers to
        cervical screening among migrant women from Eastern Europe.




        Study Type              Observational                  Current Status          Open
        Design Type             Qualitative                    Closure Date            01/01/2010
        Disease(s)              Cervix                         Sample Size             15
                                All Diseases                   Accrual to Date
                                                                                            6%
        Phase                   N/A



        Geographical Scope       UK Multi-Centre
        Lead Country             England
        Open to new sites        No

            Health care professionals can obtain a copy of the protocol by clicking here




        Main Inclusion Criteria                                Main Exclusion Criteria
        All healthcare professionals who are involved          There are no exclusion criteria.
        in the NHS cervical screening programme, or
        have the knowledge or experience of the
        target population (migrant women from
        Eastern europe).
Chief Investigator(s)
Prof Jane Wardle



Further details, please contact
Ms Marta Bartoszek


m.bartoszek@public-health.ucl.ac.uk




Funder(s)          Cancer Research UK

Sponsor(s)




                                                                                 public.ukcrn.org.uk/search
                                        If you experience problems using the application, please click here.

								
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