A Non-Interventional Follow-Up to the VELOUR Study - Translational Research
NCT ID: NCT01754272
Last Updated: 2012-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1226 participants
OBSERVATIONAL
2012-01-31
2013-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RETROSPECTIVE
Study Groups
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FOLFIRI + Aflibercept
Non-interventional study. No drugs administered. In this arm 612 patients from the VELOUR trial
No interventions assigned to this group
FOLFIRI + Placebo
Non-interventional study. 614 patients from the FOLFIRI + placebo arm in the VELOUR trial.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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KU Leuven
OTHER
Responsible Party
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Prof Sabine Tejpar
Professor
Principal Investigators
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Sabine Tejpar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Medizinische Universität Wien
Vienna, , Austria
UZ Leuven UZ Gasthuisberg 3000 Leuven
Leuven, , Belgium
Hospital Sírio E Libanês
São Paulo, , Brazil
Odense Universitetshospital
Odense C, , Denmark
SA Põhja Eesti
Tartu, , Estonia
Universitaetsklinikum Halle (Saale)
Halle, , Germany
University Hospital Of Heraklion Voutes
Heraklion, Crete, , Greece
IRCCS
Milan, , Italy
Orbis Medisch Centrum
Sittard-Geleen, , Netherlands
Oslo Universitetssykehus HF
Oslo, , Norway
Spitalul Universitar CF
Cluj-Napoca, , Romania
NN Blokhin Russian Cancer Research Center
Moscow, , Russia
Donald Gordon Medical Centre Wits University
Parktown, , South Africa
Samsung Medical Center Hematology and Oncology
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Vall d'Hebrón
Barcelona, , Spain
Akademiska Sjukhuset Onkologiska Kliniken
Uppsala, , Sweden
Mount Vernon Hospital
Greater London, , United Kingdom
Countries
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Other Identifiers
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ADX11080
Identifier Type: -
Identifier Source: org_study_id