NCT01457196已完成不适用
Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,798
- 试验地点
- 1
- 主要终点
- Proportion of Patients With a Reportable Genetic Variant
研究概览
简要总结
The primary objective of this specimen correlative study is two-fold: to provide a mechanism for the association of known molecular alterations with clinical outcomes, and to provide rapid genetic profiling of alterations with known clinical utility using tumor and germline specimens to support treatment decisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or prospective cancer patients; current cancer patients must have histologically or cytologically confirmed diagnosis of cancer
- •Tumor tissue available and suitable for molecular analyses from at least one of the following sources:
- •Tissue previously stored in UNC's Tissue Procurement Facility (TPF)
- •Tissue previous stored at an institution other than UNC-CH, provided investigators can determine that the tumors were sampled and stored under appropriate conditions for inclusion in the study
- •Patient undergoing tissue collection as per clinical standard of care and willing to allow specimens from surplus tissue to be diverted for research purposes
- •Patient undergoing tissue collection as per clinical standard of care and willing to have additional specimens taken for research
- •Patient willing to undergo biopsy for purpose of research only
- •The following inclusion criteria apply only to patients undergoing biopsy for research purposes only under this protocol:
- •≥18 years of age
- •Treatment options offer no expectation of cure, e.g., advanced solid tumor patients with metastatic disease. NOTE: This restriction applies to biopsy of vital organs only, e.g., lung, liver, etc.
- •Appropriate candidate for research biopsy based on institutional standards for target biopsy site
排除标准
- •Any condition that would make participation in the protocol unreasonably hazardous for the patient in the opinion of the treating physician
- •Dementia, altered mental status, or any psychiatric condition or co-morbid condition that would prohibit the understanding or rendering of informed consent.
- •The following exclusion criteria apply only to enrolled patients undergoing biopsy for research purposes only:
- •History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).
- •Requires general anesthesia for collection of biopsy
- •Pregnant or lactating women
- •Active cardiac disease
- •Patients receiving bevacizumab less than 6 weeks prior to enrollment into this study should not undergo research core biopsies because of the concern for potential increased bleeding risk and delayed healing. (NOTE: Patients receiving bevacizumab who are undergoing a research biopsy of accessible organs (e.g. breast, lymph node, skin etc.) must be two weeks from the last dose of the angiogenesis inhibitor).
研究组 & 干预措施
Sequencing Arm
Other
干预措施: Tumor Genetic Sequencing (Diagnostic Test)
结局指标
主要结局
Proportion of Patients With a Reportable Genetic Variant
时间窗: 1 year
To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified
Progression Free Survival
时间窗: 2 Year
Estimate Progression Free Survival (PFS) at 2 years in cancer patients with active disease with a reportable genetic variant and those without a reportable genetic variant
次要结局
未报告次要终点
研究者
研究点 (1)
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