Caris Biorepository Research Protocol

Caris Life Sciences

Status: Enrolling

Conditions: Early Detection of Cancer; Cancer; Minimal Residual Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01499394

TCBIO-001-0710

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Capacity to provide informed consent

Exclusion criteria

• 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

Trial design

100,000 participants in 5 patient groups

Normal

Description:

Donor samples reflective of a "normal" non-disease state

Newly Diagnosed Pan-Cancer Collection

Description:

Donor samples derived from treatment naïve patients with newly diagnosed solid tumors.

Early Detection Collection

Description:

Donor samples reflective of a population at increased risk for developing cancer.

Advanced Stage Cancer Collection

Description:

Donor samples derived from individuals with advanced stage cancer.

Minimal Residual Disease Collection

Description:

Donor samples obtained from individuals with a history of malignancy who are currently free of active disease