Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency of actioanble genomic abnormalites detected that modify treatment
研究概览
简要总结
Most systemic therapies are chosen on the basis of large randomized clinical trials; however, tumour heterogeneity means that cancers with similar histological features may have substantially different underlying biological drivers. The investigators propose that applying personal genomic information prospectively obtained in a clinically realistic timeframe to assist in chemotherapy decision-making could result in more effective and efficient cancer treatment. This study will investigate this approach in a cross section of advanced cancers to examine timeliness, deliverability, rate of actionable targets identified, and our ability to expand this approach into a larger clinical trial setting.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: in depth genomic sequencing (Genetic)
结局指标
主要结局
Frequency of actioanble genomic abnormalites detected that modify treatment
时间窗: up to 24 months
What is the frequency of "actionable" results in this varied tumour population ?
次要结局
- 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)