The Caris Biorepository Research Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100,000
- 试验地点
- 7
- 主要终点
- Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data.
研究概览
简要总结
The Biorepository for Caris Life Sciences is designed for the purpose of making quality biospecimens and associated clinical data available for research studies related to advancing precision medicine and improving care for patients.
The Caris Biorepository is a repository of prospectively collected biological specimens and associated clinical and demographic data gathered from multiple sources to be stored, used and shared for research. Caris Life Sciences will maintain the data and specimens and will control access to and use of the information and specimens by multiple individuals for multiple purposes which may evolve over time.
详细描述
The Caris Biorepository is an effort toward defining the future of medicine incorporating the discoveries of the genomic era by providing physicians, researchers and scientists access to quality human specimens and data aimed at improving human health and fighting disease. This will be accomplished through acquiring and sharing valuable biospecimen information and clinical outcomes in a collaborative, secure environment. The Caris Biorepository will bridge the gap and correlate human specimens with clinical and specimen data valuable to multiple and varying entities interested in advancing science with precision medicine by targeting disease treatments.
The objective of this project is to develop and implement a state-of-the-science Biorepository that ensures molecular integrity and clinical relevance of human biospecimens used in research and clinical medicine. The Caris Biorepository will also provide vital biospecimens and data to internal researchers and external research collaborators such as government, academia and industry collaborators for the use of drug development discoveries, clinically relevant research trials, publications and posters, and the implementation of future healthcare policies. This project may also impact characterization of trends in practice patterns and their relation to patient outcomes as well as the economic implications of differing evaluation, treatment and management paradigms.
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
- 是
入选标准
- •18 years of age or older
- •Capacity to provide informed consent
排除标准
- •Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients will not be approached for participation in the Caris Biorepository.
- •Minor subjects will not be included in the Caris Biorepository, as it is possible biospecimens and data may be stored beyond the time limitations of assent and it may be impracticable to re-consent these subjects once they become adults.
- •Individuals who lack the capacity to give informed consent
研究组 & 干预措施
Minimal Residual Disease Collection
Donor samples obtained from individuals with a history of malignancy who are currently free of active disease
Advanced Stage Cancer Collection
Donor samples derived from individuals with advanced stage cancer.
Normal
Donor samples reflective of a "normal" non-disease state
Newly Diagnosed Pan-Cancer Collection
Donor samples derived from treatment naïve patients with newly diagnosed solid tumors.
Early Detection Collection
Donor samples reflective of a population at increased risk for developing cancer.
结局指标
主要结局
Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data.
时间窗: 35 years
Retention of biospecimen samples with DNA
Implement release of specimens from biorepository for testing
时间窗: 35 years
Research for the purposes of cancer laboratory diagnostic tests.
次要结局
- Laboratory testing(35 years)
