The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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 - 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.
Timepoint [1] 0 0
Two years
Secondary outcome [1] 0 0
Metastatic tumor blocks - 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
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
Gender
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 status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT01754272
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01754272