- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Halle, Alemania, 06120
- Universitaetsklinikum Halle (Saale)
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
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Wien, Austria, 1090
- Medizinische Universität Wien
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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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Seoul, Corea, república de, 138-736
- Asan Medical Center
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Seoul, Corea, república de, 135-710
- Samsung Medical Center Hematology and Oncology
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Odense C, Dinamarca, 5000
- Odense Universitetshospital
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Barcelona, España, 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, Estonia, 51014
- SA Põhja Eesti
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Moscow, Federación Rusa, 115478
- NN Blokhin Russian Cancer Research Center
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Heraklion, Crete, Grecia, 71110
- University Hospital Of Heraklion Voutes
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Milano, Italia, 20133
- IRCCS
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Oslo, Noruega, 0407
- Oslo universitetssykehus HF
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Sittard-Geleen, Países Bajos, 6162
- Orbis Medisch Centrum
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Greater London, Reino Unido, HA6 2RN
- Mount Vernon Hospital
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Cluj Napoca, Rumania, 400015
- Spitalul Universitar CF
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Parktown, Sudáfrica, 2193
- Donald Gordon Medical Centre Wits University
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Uppsala, Suecia, 751 85
- Akademiska Sjukhuset Onkologiska Kliniken
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients who have participated in the VELOUR trial
Exclusion Criteria:
- Patients who have not participated in the VELOUR trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Primary colorectal cancer tumor blocks
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Metastatic tumor blocks
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Residual blood samples
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ADX11080
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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