- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01904916
CPCT-05 Biopsy Protocol Patient Selection
Protocol to Obtain Tumor Biopsies From Patients With Locally Advanced (Incurable) or Metastatic Cancer to Improve Selection for Clinical Trials. (CPCT - 05 Biopsy Protocol Patient Selection)
Our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly testing drugs in mainly metastatic cancer patient populations with rare mutations. Successful examples of this new strategy are ALK inhibitors in ALK translocated NSCLC (less than 5% frequency) and EGFR inhibitors in EGFR mutant NSCLC (approximately 5% frequency). Selecting molecularly stratified patient populations for studies benefits the patient as it increases the odds of obtaining benefit from experimental treatment, especially in early clinical trials. Moreover it increases the speed and efficacy of drug development as signs of efficacy are picked up in earlier phases. Therefore, broad screening of molecular lesions in the tumors of patients that are being considered for participation in trials is crucial. This pre-selection increases our ability to perform several trials in parallel and thus include more patients in more meaningful trials. With the still dismal prognosis of patients with metastatic cancer, increasing the accrual rate to pivotal trials in selected patient populations is a key factor in improving prognosis.
The advent of Next Generation Sequencing (NGS) platforms enables us to probe a limited number of cancer related genes within 2-4 weeks. We have extensively piloted this approach and are now able to deliver clinically meaningful turn-around-times. This development enables us to use this technology to enrich clinical trials using targeted therapies for patients with specific mutations.
We will obtain tumor biopsies of a metastatic or locally advanced lesion and a peripheral blood sample from all patients included in the trial; the biopsies to obtain information on the tumor related genetic mutations (mutational profile) and the blood samples to assess each patient's germline DNA background variation. As patients will be asked to undergo an invasive procedure it is important to address the potential safety issues. Review of the literature and our own experience show that tumor biopsies can be performed with only minor complications and acceptable risks. We will recruit patients with metastatic or locally advanced solid tumors from patients that can potentially be included in clinical trials.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Amsterdam, 네덜란드
- Antoni van Leeuwenhoek Ziekenhuis
-
Rotterdam, 네덜란드
- Erasmus Medical Center
-
Utrecht, 네덜란드, 3508 GX
- University Medical Center Utrecht
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Locally advanced (incurable) or metastatic cancer from a histological or cytological proven solid tumor
- Indication for systemic treatment with anti-cancer agents (with no treatment options with curative intent)
- Measurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria.
- Safe biopsy of a metastatic or locally advanced lesion possible
- No contraindications for lidocaine (or its derivatives) and/or midazolam and/or phentanyl
- Adequate organ function
- WHO performance status 0-2
- Age > 18 yr
- Expected adequacy to follow up
- Written informed consent
Exclusion Criteria:
• If one or more of the above mentioned inclusion criteria is not met
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: Histological biopsy procedure
This is a diagnostic multicenter study combining histological biopsy of tumor material with DNA sequencing using Ion Torrent®, Next Generation Sequencing (NGS) platform.
The study aims improve stratification of cancer patients by obtaining fresh tumor biopsies for next-generation sequencing for participation in clinical trials.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Percentage of screened patients allocated to trials based upon outcome of genetic screening effort.
기간: 1 year
|
1 year
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Number and nature of (serious) adverse events of the performed histological biopsies.
기간: 2 days after each biopsy procedure
|
2 days after each biopsy procedure
|
Number of samples stored for future related research.
기간: 1 year
|
1 year
|
Number of samples with an adequate microRNA, (phospho)proteomic profiles and organoid cultures that allows biomarker discovery efforts. These profiles will be deposited in the CPCT database.
기간: 1 year
|
1 year
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Marlies Langenberg, MD, PhD, UMC Utrecht
- 수석 연구원: Neeltje Steeghs, MD, PhD, Antoni van Leeuwenhoek Hospital
- 수석 연구원: Maja J.A. de Jonge, MD, PhD, Erasmus Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
고형 종양에 대한 임상 시험
-
AstraZeneca모병Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, 위암, 유방암 및 난소암스페인, 미국, 벨기에, 영국, 프랑스, 헝가리, 캐나다, 대한민국, 호주