- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01802905
Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies
연구 개요
상세 설명
It is clear that carcinogenesis is an immensely complex process and that even within a histologic cancer subtype - such as adenocarcinoma of the lung or breast - there is significant heterogeneity in cancer behaviour and response to therapy. Recognizing genetic mutations that promote disease facilitates targeted treatment; this has been demonstrated in several small subgroups of cancers in which specific genetic mutations or translocations have been successfully treated with targeted chemotherapy agents.
Analyses of individual patients demonstrate unique molecular signatures for every cancer examined. Frequently, multiple different pathways are involved in disease growth and progression and the dominant process varies from person to person and perhaps even within different sites of disease within one person. As well these variations evolve in response to treatment. With many recognized mutations personalized evaluation of the genetic signature encoded in DNA and RNA may enable directed therapy to the appropriate oncologic pathway thereby providing information to help guide chemotherapy choices.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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British Columbia
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Vancouver, British Columbia, 캐나다
- BC Cancer Agency
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subjects must have histologically or cytologically confirmed diagnosis of cancer
- This cancer must be incurable, as defined by their treating oncologist (generally because of advanced stage).
- Subjects must agree to provide archival tissue and agree to undergo a study specific biopsy and blood test for genetic analysis. All subjects would have a biopsy and blood samples at progression if it could be done safely.
- ECOG PS 0 or 1.
- Age > 18 years of age.
- Subject consent must be obtained according to the BCCA requirements.
- Subject must be accessible for treatment and follow-up. Subjects must be registered at the BCCA Vancouver site.
Exclusion Criteria:
- Unable or unwilling to undergo tumour biopsy(s) and/or blood/skin samples for normal DNA.
- Significant medical condition that in the opinion of the treating oncologist renders the subject not suitable for participation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Sequenced patients
Patients enrolled on the study who have successful sequencing of their cancers will be closely monitored for: what chemotherapy agents are next used, what response and toxicity do they have, is there any early sign of response detected on PET-CT, overall did the genomic information change treatment decision-making.
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Fresh tumour biopsies and matched normal specimens (blood and surrounding tissue) and when possible archival pretreatment specimens, will undergo in depth DNA and RNA sequencing and analysis on an oncogene panel.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Frequency of actioanble genomic abnormalites detected that modify treatment
기간: up to 24 months
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What is the frequency of "actionable" results in this varied tumour population ?
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up to 24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test
기간: up to 24 months
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What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.
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up to 24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Janessa J. Laskin, MD FRCPC, British Columbia Cancer Agency
- 수석 연구원: Marco Marra, PhD FRSC, Genome Sciences Centre, BC Cancer Agency
간행물 및 유용한 링크
일반 간행물
- Peixoto RD; Li Y; Pleasance E; Yip S; et al. A case of the utilization of genomic information in the management of metastatic colorectal cancer. J Clin Oncol 30: 2012 (suppl 34; abstr 444)
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 (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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