Caris Biorepository Research Protocol

Cancer Clinical Trial

Official title:

The Caris Biorepository Research Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01499394
• Other study ID #: TCBIO-001-0710
• Status: Recruiting
• Start date: November 2010
• Est. completion date: November 2025

Study information

• Verified date: January 2020
• Source: Caris Science, Inc.
• Contact: Mary Baker
• Email: carisresearch[@]carisls.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: November 2025
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	Phoebe Putney Memorial Hospital	Albany	Georgia
United States	Overlake Hospital	Bellevue	Washington
United States	CAMC Clinical Trials	Charleston	West Virginia
United States	Advantage Clinical Research	Nashville	Tennessee
United States	Eastern Carolina Women's Center	New Bern	North Carolina
United States	Walla Walla Clinic	Walla Walla	Washington
United States	The Iowa Clinic, PC	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Caris Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data.	Retention of biospecimen samples with DNA	5 years
Primary	Implement release of specimens from biorepository for testing	Research for the purposes of cancer laboratory diagnostic tests.	5 years
Secondary	Laboratory testing	DNA and RNA microarray	5 years
Secondary	Laboratory testing	Immunohistochemistry	5 years
Secondary	Laboratory testing	Gene and protein expression, proteomics and matabolomics	5 years
Secondary	Laboratory testing	Mutation analysis	5 years
Secondary	Laboratory testing	Experiemental lab testing for development of new diagnostic technology	5 years
Secondary	Laboratory testing	Microvesicle discovery, characterization and validation.	5 years