PRospective REgistry of Advanced Stage CancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations Using the OmniSeq Test and Creation of a Biobank from Community Cancer Clinics in the United States to Address Disparities in Precision Medicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,429
- 试验地点
- 1
- 主要终点
- The percent adoption of the OmniSeq next generation sequencing (NGS) testing platform in an advanced cancer patient population compared to baseline over a 2 year period
研究概览
简要总结
The objective of this Study is to collect, process, and transfer biologic samples such as blood and/or tissue biopsies to determine the concordance of detected alterations obtained through liquid biopsy analyses compared to next generation sequencing of time-matched or archival tissue specimens from individuals with advanced solid tumors.
Examples of locally advanced and metastatic tumors include stage III and IV cancers (ex. lung, breast, all gastrointestinal malignancies, all gynecologic malignancies, prostate cancer, head and neck tumors, soft tissue cancers, and melanoma). These specimens will be analyzed for diagnostic purposes and research (either by Labcorp/OmniSeq or to a third-party recipient designated by Labcorp/OmniSeq). Labcorp/OmniSeq may transfer the specimens and data to its clients, including commercial, academic or non-profit research institutions; or alternatively, may retain the specimens in its repository for future research use at the sole discretion of Labcorp/OmniSeq and or assignees. Labcorp/OmniSeq will maintain all detailed clinical information including demographic data (de-identified), ethnicity, disease state, stage (radiological, pathological and clinical-whichever is relevant).
详细描述
The scope of this pilot includes increasing uptake of personalized medicine (PM) testing using the OmniSeq test for identifying actionable target mutations in clinically appropriate patients and improving the quality of care particularly in practices providing care to minority and underserved patient populations. The research scope of this pilot covers 3 major areas that are necessary to understand the feasibility and best approaches.
i. How to identify appropriate steps and strategies to improve compliance to achieve optimum testing for all cancer patients, including all minority patients, in accordance with approved guidelines.
ii. How to contact, trace and test all eligible patients and impact outcomes to prevent future cancers in unaffected relatives
iii. Impact of trace back approach to identify, test, and guide appropriate clinical management and intervention in patients already diagnosed with eligible cancer types who have not yet been tested. This can be done by: 1) searching pathology records or tumor registry databases 2) community engagement campaigns and 3) self-referral based on family (and/or personal) cancer history.
The PREFER Registry will enable Labcorp/OmniSeq to create a biorepository in addition to a registry. The benefits are as follows:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The percent adoption of the OmniSeq next generation sequencing (NGS) testing platform in an advanced cancer patient population compared to baseline over a 2 year period
时间窗: 2 years
次要结局
未报告次要终点