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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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