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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- Thomas Jefferson University Hospital
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Greater London、イギリス、HA6 2RN
- Mount Vernon Hospital
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Milano、イタリア、20133
- IRCCS
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Tartu、エストニア、51014
- SA Põhja Eesti
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Sittard-Geleen、オランダ、6162
- Orbis Medisch Centrum
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Western Australia
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Nedlands、Western Australia、オーストラリア、6009
- Sir Charles Gairdner Hospital
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Wien、オーストリア、1090
- Medizinische Universitat Wien
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Heraklion, Crete、ギリシャ、71110
- University Hospital Of Heraklion Voutes
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Uppsala、スウェーデン、751 85
- Akademiska Sjukhuset Onkologiska Kliniken
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Barcelona、スペイン、08035
- Hospital Vall d'Hebron
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Odense C、デンマーク、5000
- Odense Universitetshospital
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Halle、ドイツ、06120
- Universitaetsklinikum Halle (Saale)
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Oslo、ノルウェー、0407
- Oslo universitetssykehus HF
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Sao Paulo、ブラジル、01308050
- Hospital Sírio E Libanês
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Leuven、ベルギー、3000
- UZ Leuven UZ Gasthuisberg 3000 Leuven
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Cluj Napoca、ルーマニア、400015
- Spitalul Universitar CF
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Moscow、ロシア連邦、115478
- NN Blokhin Russian Cancer Research Center
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Parktown、南アフリカ、2193
- Donald Gordon Medical Centre Wits University
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Seoul、大韓民国、138-736
- Asan Medical Center
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Seoul、大韓民国、135-710
- Samsung Medical Center Hematology and Oncology
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients who have participated in the VELOUR trial
Exclusion Criteria:
- Patients who have not participated in the VELOUR trial
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Primary colorectal cancer tumor blocks
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Metastatic tumor blocks
時間枠: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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Residual blood samples
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Sabine Tejpar, MD, PhD、KU Leuven
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
転移性結腸直腸がんの臨床試験
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