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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
ADX11080
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary colorectal cancer tumor blocks
Timepoint [1] 0 0
Two years
Secondary outcome [1] 0 0
Metastatic tumor blocks
Timepoint [1] 0 0
Two years

Eligibility
Key inclusion criteria
* Patients who have participated in the VELOUR trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who have not participated in the VELOUR trial

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2013
Actual
Sample size
Target
Accrual to date
Final
1226
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Denmark
State/province [5] 0 0
Odense C
Country [6] 0 0
Estonia
State/province [6] 0 0
Tartu
Country [7] 0 0
Germany
State/province [7] 0 0
Halle
Country [8] 0 0
Greece
State/province [8] 0 0
Heraklion, Crete
Country [9] 0 0
Italy
State/province [9] 0 0
Milano
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Netherlands
State/province [11] 0 0
Sittard-Geleen
Country [12] 0 0
Norway
State/province [12] 0 0
Oslo
Country [13] 0 0
Romania
State/province [13] 0 0
Cluj Napoca
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Moscow
Country [15] 0 0
South Africa
State/province [15] 0 0
Parktown
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Sweden
State/province [17] 0 0
Uppsala
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Greater London

Funding & Sponsors
Primary sponsor type
Other
Name
KU Leuven
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sabine Tejpar, MD, PhD
Address 0 0
KU Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01754272