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

2012年12月18日 更新者：Prof Sabine Tejpar、KU Leuven

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.

研究概览

地位

未知

条件

详细说明

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.

研究类型

观察性的

注册 (实际的)

1226

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Odense C、丹麦、5000
        • Odense Universitetshospital
  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、115478
        • NN Blokhin Russian Cancer Research Center
  • 南非
      • Parktown、南非、2193
        • Donald Gordon Medical Centre Wits University
  • 大韩民国
      • Seoul、大韩民国、138-736
        • Asan Medical Center
      • Seoul、大韩民国、135-710
        • Samsung Medical Center Hematology and Oncology
  • 奥地利
      • Wien、奥地利、1090
        • Medizinische Universität Wien
  • 巴西
      • Sao Paulo、巴西、01308050
        • Hospital Sírio E Libanês
  • 希腊
      • Heraklion, Crete、希腊、71110
        • University Hospital Of Heraklion Voutes
  • 德国
      • Halle、德国、06120
        • Universitaetsklinikum Halle (Saale)
  • 意大利
      • Milano、意大利、20133
        • IRCCS
  • 挪威
      • Oslo、挪威、0407
        • Oslo Universitetssykehus HF
  • 比利时
      • Leuven、比利时、3000
        • UZ Leuven UZ Gasthuisberg 3000 Leuven
  • 澳大利亚
    • Western Australia
      • Nedlands、Western Australia、澳大利亚、6009
        • Sir Charles Gairdner Hospital
  • 爱沙尼亚
      • Tartu、爱沙尼亚、51014
        • SA Põhja Eesti
  • 瑞典
      • Uppsala、瑞典、751 85
        • Akademiska Sjukhuset Onkologiska Kliniken
  • 罗马尼亚
      • Cluj Napoca、罗马尼亚、400015
        • Spitalul Universitar CF
  • 美国
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • Thomas Jefferson University Hospital
  • 英国
      • Greater London、英国、HA6 2RN
        • Mount Vernon Hospital
  • 荷兰
      • Sittard-Geleen、荷兰、6162
        • Orbis Medisch Centrum
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Vall d'hebrón

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

Inclusion Criteria:

  • Patients who have participated in the VELOUR trial

Exclusion Criteria:

  • Patients who have not participated in the VELOUR trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Primary colorectal cancer tumor blocks
大体时间：Two years
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.
Two years

次要结果测量

结果测量
措施说明
大体时间
Metastatic tumor blocks
大体时间：Two years
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
Two years

其他结果措施

结果测量
措施说明
大体时间
Residual blood samples
大体时间：Two years
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.
Two years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

KU Leuven

调查人员

  • 首席研究员：Sabine Tejpar, MD, PhD、KU Leuven

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (预期的)

2013年12月1日

研究完成 (预期的)

2013年12月1日

研究注册日期

首次提交

2012年12月12日

首先提交符合 QC 标准的

2012年12月18日

首次发布 (估计)

2012年12月21日

研究记录更新

最后更新发布 (估计)

2012年12月21日

上次提交的符合 QC 标准的更新

2012年12月18日

最后验证

2012年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ADX11080

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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