Overview

This trial is active, not recruiting.

Condition cancer
Sponsor Caris Science, Inc.
Start date November 2010
End date November 2020
Trial size 100000 participants
Trial identifier NCT01499394, TCBIO-001-0710

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Donor samples reflective of a "normal" non-disease state
Donor samples reflective of a known disease state or condition

Primary Outcomes

Measure
Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data.
time frame: 5 years
Implement release of specimens from biorepository for testing
time frame: 5 years

Secondary Outcomes

Measure
Laboratory testing
time frame: 5 years
Laboratory testing
time frame: 5 years
Laboratory testing
time frame: 5 years
Laboratory testing
time frame: 5 years
Laboratory testing
time frame: 5 years
Laboratory testing
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Caris Biorepository Research Protocol
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Caris Science, Inc..