NCT01443390已完成不适用
An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advanced Refractory Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- to identify as many genomic changes as possible in advanced cancers, so as to expand the range of potential actionable targets with therapies that were commercially available or clinical trials
研究概览
简要总结
When a patient with advanced cancer consults with a member of the Phase I drug development team, the investigators utilize all information possible to try to select a therapy for that patient which has the best chance of working for them. This information includes:
- Past published information
- Clinical experience and judgement
- Immunohistochemistry for specific targets (e.g., ER)
- Standard sequencing (e.g., for K-Ras) and other methods now available.
The investigators have a new tool which warrants early exploration for what role it might eventually play in the process of selecting the best therapy for an individual patient. The basis of the current ancillary exploratory study is to gain initial experience with the operational aspects of this whole genome sequencing in this setting.
详细描述
- To measure the time from biopsy to completion and final analysis of Whole Genome Sequencing (WGS) on patient tumor and non-tumor samples.
- To examine the frequency with which useable sequence data is obtained as a function of tumor volume received and percent tumor involvement in the biopsy
- To identify the frequency with which potential targets and pathways for therapy are discovered.
- To observe for any evidence that if anti-tumor activity from treatment is noted how would the genome sequencing have correlated with that activity.
研究设计
- 研究类型
- Observational
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
- •Have a life expectancy of greater than 3 months.
- •Patients must have a diagnosis of histologically or cytologically confirmed advanced incurable cancer which has progressed on one or more prior chemotherapeutic, hormonal or biological regimens for advanced disease.
- •Be a good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.
排除标准
- •Patients with symptomatic CNS metastasis.
- •Known HIV, HBV or HCV infection requiring antiviral therapy.
- •Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
- •Inaccessible tumor for biopsy
结局指标
主要结局
to identify as many genomic changes as possible in advanced cancers, so as to expand the range of potential actionable targets with therapies that were commercially available or clinical trials
时间窗: 12 months
次要结局
未报告次要终点
研究者
Glen Weiss
Director, Clinical Research
Cancer Treatment Centers of America
研究点 (1)
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