- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Heraklion, Crete, 그리스, 71110
- University Hospital Of Heraklion Voutes
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Parktown, 남아프리카, 2193
- Donald Gordon Medical Centre Wits University
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Sittard-Geleen, 네덜란드, 6162
- Orbis Medisch Centrum
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Oslo, 노르웨이, 0407
- Oslo universitetssykehus HF
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Seoul, 대한민국, 138-736
- Asan Medical Center
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Seoul, 대한민국, 135-710
- Samsung Medical Center Hematology and Oncology
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Odense C, 덴마크, 5000
- Odense Universitetshospital
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Halle, 독일, 06120
- Universitaetsklinikum Halle (Saale)
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Moscow, 러시아 연방, 115478
- NN Blokhin Russian Cancer Research Center
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Cluj Napoca, 루마니아, 400015
- Spitalul Universitar CF
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Thomas Jefferson University Hospital
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Leuven, 벨기에, 3000
- UZ Leuven UZ Gasthuisberg 3000 Leuven
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Sao Paulo, 브라질, 01308050
- Hospital Sírio E Libanês
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Uppsala, 스웨덴, 751 85
- Akademiska Sjukhuset Onkologiska Kliniken
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Barcelona, 스페인, 08035
- Hospital Vall d'Hebron
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Tartu, 에스토니아, 51014
- SA Põhja Eesti
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Greater London, 영국, HA6 2RN
- Mount Vernon Hospital
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Wien, 오스트리아, 1090
- Medizinische Universität Wien
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Milano, 이탈리아, 20133
- IRCCS
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Western Australia
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Nedlands, Western Australia, 호주, 6009
- Sir Charles Gairdner Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients who have participated in the VELOUR trial
Exclusion Criteria:
- Patients who have not participated in the VELOUR trial
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Primary colorectal cancer tumor blocks
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Metastatic tumor blocks
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Residual blood samples
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Sabine Tejpar, MD, PhD, KU Leuven
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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