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- Ensaio Clínico NCT01754272
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Halle, Alemanha, 06120
- Universitaetsklinikum Halle (Saale)
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Western Australia
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Nedlands, Western Australia, Austrália, 6009
- Sir Charles Gairdner Hospital
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Sao Paulo, Brasil, 01308050
- Hospital Sírio E Libanês
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Leuven, Bélgica, 3000
- UZ Leuven UZ Gasthuisberg 3000 Leuven
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Odense C, Dinamarca, 5000
- Odense Universitetshospital
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Barcelona, Espanha, 08035
- Hospital Vall d'Hebron
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University Hospital
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Tartu, Estônia, 51014
- SA Põhja Eesti
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Moscow, Federação Russa, 115478
- NN Blokhin Russian Cancer Research Center
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Heraklion, Crete, Grécia, 71110
- University Hospital Of Heraklion Voutes
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Sittard-Geleen, Holanda, 6162
- Orbis Medisch Centrum
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Milano, Itália, 20133
- IRCCS
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Oslo, Noruega, 0407
- Oslo universitetssykehus HF
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Greater London, Reino Unido, HA6 2RN
- Mount Vernon Hospital
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Seoul, Republica da Coréia, 138-736
- Asan Medical Center
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Seoul, Republica da Coréia, 135-710
- Samsung Medical Center Hematology and Oncology
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Cluj Napoca, Romênia, 400015
- Spitalul Universitar CF
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Uppsala, Suécia, 751 85
- Akademiska Sjukhuset Onkologiska Kliniken
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Parktown, África do Sul, 2193
- Donald Gordon Medical Centre Wits University
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Wien, Áustria, 1090
- Medizinische Universität Wien
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients who have participated in the VELOUR trial
Exclusion Criteria:
- Patients who have not participated in the VELOUR trial
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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FOLFIRI + Aflibercept
Non-interventional study.
No drugs administered.
In this arm 612 patients from the VELOUR trial
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FOLFIRI + Placebo
Non-interventional study.
614 patients from the FOLFIRI + placebo arm in the VELOUR trial.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Primary colorectal cancer tumor blocks
Prazo: Two years
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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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Two years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Metastatic tumor blocks
Prazo: Two years
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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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Two years
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Residual blood samples
Prazo: Two years
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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.
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Two years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sabine Tejpar, MD, PhD, KU Leuven
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ADX11080
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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