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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01754272
Registration number
NCT01754272
Ethics application status
Date submitted
12/12/2012
Date registered
21/12/2012
Date last updated
21/12/2012
Titles & IDs
Public title
A Non-Interventional Follow-Up to the VELOUR Study - Translational Research
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Scientific title
A Non-Interventional Follow-Up to the VELOUR Study (Multicentre International Study of Aflibercept Versus Placebo in Combination With FOLFIRI for Metastatic Colorectal Cancer) - Translational Research
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Secondary ID [1]
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ADX11080
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
FOLFIRI + Aflibercept - Non-interventional study. No drugs administered. In this arm 612 patients from the VELOUR trial
FOLFIRI + Placebo - Non-interventional study. 614 patients from the FOLFIRI + placebo arm in the VELOUR trial.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary colorectal cancer tumor blocks
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Assessment method [1]
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Identify and acquire as many archived primary tumor blocks as possible of patients with mCRC treated in The VELOUR trial. Process the acquired samples as part of a translation research program.
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Timepoint [1]
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Two years
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Secondary outcome [1]
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Metastatic tumor blocks
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Assessment method [1]
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Identify and acquire as many archived metastatic tumor tissue blocks as possible of patients with mCRC treated in The VELOUR trial. Process the acquired samples as part of a translation research program.Process the acquired samples as part of a translation research program
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Timepoint [1]
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Two years
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Eligibility
Key inclusion criteria
- Patients who have participated in the VELOUR trial
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients who have not participated in the VELOUR trial
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2013
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Actual
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Sample size
Target
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Accrual to date
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Final
1226
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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State/province [1]
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Pennsylvania
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Austria
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State/province [2]
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Wien
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Belgium
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State/province [3]
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Leuven
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Brazil
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Sao Paulo
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Denmark
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Odense C
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Estonia
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Tartu
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Germany
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Halle
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Greece
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Heraklion, Crete
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Italy
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Milano
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Country [10]
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Korea, Republic of
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State/province [10]
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Seoul
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Netherlands
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State/province [11]
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Sittard-Geleen
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Country [12]
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Norway
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State/province [12]
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Oslo
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Romania
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State/province [13]
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Cluj Napoca
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Country [14]
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Russian Federation
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State/province [14]
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Moscow
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South Africa
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State/province [15]
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Parktown
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Spain
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State/province [16]
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Barcelona
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Sweden
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State/province [17]
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Uppsala
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Country [18]
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United Kingdom
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State/province [18]
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Greater London
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Funding & Sponsors
Primary sponsor type
Other
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Name
KU Leuven
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a follow-on study to the VELOUR trial (NCT00561470). The aim of this study is to
acquire the archived colorectal cancer and metastasized tissue tumour blocks of patients who
have participated in the VELOUR study.
These samples will be analysed to find proteins or markers which represent how an individual
may be responding to treatment. The identification of these markers may help provide
personalised and more effective treatment programs for patients with similar conditions in
the future.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01754272
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sabine Tejpar, MD, PhD
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Address
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KU Leuven
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01754272
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