Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
British Columbia
-
Vancouver、British Columbia、加拿大
- BC Cancer Agency
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
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.
|
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 |
|---|---|---|
|
Frequency of actioanble genomic abnormalites detected that modify treatment
大体时间:up to 24 months
|
What is the frequency of "actionable" results in this varied tumour population ?
|
up to 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test
大体时间:up to 24 months
|
What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.
|
up to 24 months
|
合作者和调查者
调查人员
- 首席研究员:Janessa J. Laskin, MD FRCPC、British Columbia Cancer Agency
- 首席研究员:Marco Marra, PhD FRSC、Genome Sciences Centre, BC Cancer Agency
出版物和有用的链接
一般刊物
- 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)
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.