Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Caris Biorepository Research Protocol

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Caris Science, Inc. Identifier:
First received: December 16, 2011
Last updated: June 7, 2016
Last verified: June 2016

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Caris Biorepository Research Protocol

Further study details as provided by Caris Science, Inc.:

Primary Outcome Measures:
  • Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Retention of biospecimen samples with DNA

  • Implement release of specimens from biorepository for testing [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Research for the purposes of cancer laboratory diagnostic tests.

Secondary Outcome Measures:
  • Laboratory testing [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    DNA and RNA microarray

  • Laboratory testing [ Time Frame: 5 years ] [ Designated as safety issue: No ]

  • Laboratory testing [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Gene and protein expression, proteomics and matabolomics

  • Laboratory testing [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Mutation analysis

  • Laboratory testing [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Experiemental lab testing for development of new diagnostic technology

  • Laboratory testing [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Microvesicle discovery, characterization and validation.

Biospecimen Retention:   Samples With DNA
Currently plasma with an opportunity to collect other biospecimens

Estimated Enrollment: 100000
Study Start Date: November 2010
Estimated Study Completion Date: November 2025
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Donor samples reflective of a "normal" non-disease state
Disease state or condition
Donor samples reflective of a known disease state or condition

Detailed 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers as well as those with a known disease state or condition

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01499394

United States, Arizona
Banner Health
Phoenix, Arizona, United States, 85006
United States, California
John Muir Clinical Research Center
Concord, California, United States, 94520
Breastlink Medical Group
Orange, California, United States, 92868
United States, Colorado
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
United States, Indiana
Community Cancer Research Foundation
Munster, Indiana, United States, 46321
United States, Iowa
The Iowa Clinic, PC
West Des Moines, Iowa, United States, 50266
United States, Nevada
Renown Health
Reno, Nevada, United States, 89502
United States, North Carolina
Comprehensive Cancer Center of Pardee
Hendersonville, North Carolina, United States, 28791
Eastern Carolina Women's Center
New Bern, North Carolina, United States, 28562
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Washington
Overlake Hospital
Bellevue, Washington, United States, 98004
United States, West Virginia
CAMC Clinical Trials
Charleston, West Virginia, United States, 25304
Sponsors and Collaborators
Caris Science, Inc.
  More Information

Responsible Party: Caris Science, Inc. Identifier: NCT01499394     History of Changes
Other Study ID Numbers: TCBIO-001-0710 
Study First Received: December 16, 2011
Last Updated: June 7, 2016
Health Authority: United States: Institutional Review Board processed this record on October 21, 2016