Implementation of Comprehensive Molecular Profiling and Deep Clinical Annotation of Electronic Health Records in Participants Diagnosed With or at Risk of Developing Cancer (ASAP Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25,000
- 试验地点
- 2
- 主要终点
- Percent of patients participating in comprehensive molecular profiling
研究概览
简要总结
The purpose of this study is to understand the breadth of molecular characteristics present in participants cared for in a large integrated, community-based health care system. Using comprehensive genomic profiling and proteomics, the investigators seek to identify the underlying genomic drivers of premalignant or malignant conditions in participants across different stages of disease development and cancer types.
Comprehensive molecular profiling will consist of somatic tumor testing (tissue and/or blood) using whole exome sequencing, whole transcriptome sequencing, proteomics, and selected instances of whole genome sequencing. In addition, the investigators seek to perform broad hereditary cancer testing in affected participant populations. Hereditary testing has implications in screening, prognosis, and therapeutics for affected participants, as well as broad implications for genetic counseling and cascade testing.
In order to maximize the value of genomic information, participants consented to this protocol will have their electronic health records (both retrospectively and prospectively) abstracted, curated, annotated and linked to genomic information obtained though the testing performed. Given the long-term value of this data, participants will also be asked to voluntarily consent to have their samples stored in a biobank and have their de-identified information used for future research.
Information collected across this participant population will aid in advancing the investigators' knowledge of cancer biology, to discover and validate biomarkers associated with clinical outcomes, and shared in collaborative projects in order to promote the study of cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Must be at least 18 years of age
- •Must be undergoing a workup or being followed for a premalignant condition or have a diagnosis of cancer
- •Must voluntarily sign and understand the most current IRB-approved consent form prior to study participation
排除标准
- •Participants incapable of understanding the items listed in the consent form and process
- •Participants with a history of or known psychiatric illness deemed unable to consent or adhere to study requirements
结局指标
主要结局
Percent of patients participating in comprehensive molecular profiling
时间窗: 5 years
Percent of patients referred for cascade genetic testing
时间窗: 5 years
Percent of patients referred for molecularly targeted clinical trials
时间窗: 5 years
次要结局
- Percent of patients that had therapy changed due to comprehensive molecular profiling(5 years)
- Percent of patients that had therapy changed due to pharmacogenomic testing(5 years)
- Percent of patient participating in microbiome collection and analysis(5 years)