Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Non-Interventional Follow-Up to the VELOUR Study - Translational Research

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof Sabine Tejpar, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01754272
First received: December 12, 2012
Last updated: December 18, 2012
Last verified: December 2012

December 12, 2012
December 18, 2012
January 2012
December 2013   (final data collection date for primary outcome measure)
Primary colorectal cancer tumor blocks [ Time Frame: Two years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01754272 on ClinicalTrials.gov Archive Site
Metastatic tumor blocks [ Time Frame: Two years ] [ Designated as safety issue: No ]
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
Same as current
Residual blood samples [ Time Frame: Two years ] [ Designated as safety issue: No ]
Acess as many residual blood samples (plasma, serum) collected in the frame of the VELOUR study as possible. Process the samples to determine markers relevant to angiogenesis factors, response to aflibercept and other markers which will be defined by the steering committee.
Same as current
 
A Non-Interventional Follow-Up to the VELOUR Study - Translational Research
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

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.

The VELOUR trial (NCT00561470) has demonstrated the efficacy of aflibercept as a second line treatment in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI)for metastatic colorectal cancer (mCRC) patients refractory to a first line oxaliplatin based chemotherapy regimen (Van Cutsem E., JCO 30 (2012):pp3499-3506). The FDA has approved Aflibercept (Zaltrap) for the treatment of metastatic colorectal cancer in combination with FOLFIRI on August 3rd 2012 and by European Medical Agency (EMEA) on November 15th 2012.

While the VELOUR study confirmed the benefits of using aflibercept in combination with FOLFIRI, the availability of biomarkers accurately predicting patients responding to this combination would further improve clinical utility of this drug. The molecular profiling of the Formaldehyde fixed paraffin embedded (FFPE) clinical tumor samples and serial plasma samples obtained from patients involved in VELOUR study and subsequent analysis of the molecular and clinical data would provide an invaluable opportunity to discover and potentially validate such biomarkers.

As blocks were not collected as part of the VELOUR trial, this protocol deals primarily with the steps that will be taken to gain ethics and consent in each of the participating countries and how the blocks will then be sourced and acquired, finally deposited in a biobank situated in KULeuven.

A VELOUR Translational Research Consortium (VTRC) has been formed by the Catholic University of Leuven (KULeuven)and Almac Diagnostics for the realisation of this study. The number of blocks available based on the surgical list held for the trial is estimated at 1030 (84% of complete trial cohort) and from a profiling viewpoint it has been calculated that the minimum number of blocks acceptable for processing and biomarker identification / validation is 500.

Due to the specific interest in angiogenesis, the VTRC consortium will aim to source blocks with both tumor and surrounding stromal tissue which will then be macro-dissected with the aim to generate data for both the tumor and surrounding angiogenic stroma. The project will generate gene expression, immunohistochemistry (IHC) and mutational data for these samples. In addition single nucleotide polymorphisms (SNP) data will be generated from non-tumor tissue, focusing on polymorphisms that demonstrate an association with disease or response outcome to therapy. Pre-processing and in silico evaluation of all data generated will support the outcome objectives of this study.

Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Archived FFPE (Formaldehyde fixed paraffin-embedded) primary tumour colorectal cancer tissues Archived FFPE (Formaldehyde fixed paraffin-embedded) metastatic tumour tissue Archived residual blood samples (plasma, serum) collected in the frame of the VELOUR trial

Non-Probability Sample

Patients with metastaic colorectal cancer who were refractory to an oxaliplatin-based chemotherapy.

Metastatic Colorectal Cancer
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1226
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have participated in the VELOUR trial

Exclusion Criteria:

  • Patients who have not participated in the VELOUR trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Denmark,   Estonia,   Germany,   Greece,   Italy,   Korea, Republic of,   Netherlands,   Norway,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT01754272
ADX11080
No
Prof Sabine Tejpar, Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
Not Provided
Principal Investigator: Sabine Tejpar, MD, PhD Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP