Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions

UNC Lineberger Comprehensive Cancer Center1 个研究点分布在 1 个国家目标入组 2,798 人2011年9月

适应症Neoplasm

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Neoplasm
发起方: UNC Lineberger Comprehensive Cancer Center
入组人数: 2798
试验地点: 1
主要终点: Proportion of Patients With a Reportable Genetic Variant
状态: 已完成
最后更新: 6年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2011年9月

结束日期

2018年6月6日

最后更新

6年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

UNC Lineberger Comprehensive Cancer Center

责任方

Sponsor

入排标准

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.

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).

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