Caris Biorepository Research Protocol

January 19, 2026 updated by: Caris Science, Inc.

The Caris Biorepository Research Protocol

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 Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
    • Arizona
      • Scottsdale, Arizona, United States
        • Recruiting
        • Southwest Medical Imaging
        • Contact:
    • Arkansas
      • Jonesboro, Arkansas, United States
        • Recruiting
        • St. Bernards Medical Center
        • Contact:
      • Little Rock, Arkansas, United States
        • Recruiting
        • CARTI Cancer Center
        • Contact:
      • Little Rock, Arkansas, United States
    • Florida
      • Fort Myers, Florida, United States
      • Lake City, Florida, United States
      • Orlando, Florida, United States
      • Tampa, Florida, United States
        • Recruiting
        • The University of South Florida
        • Contact:
      • Weston, Florida, United States
        • Recruiting
        • Cleveland Clinic Florida
        • Contact:
    • Georgia
      • Albany, Georgia, United States, 31701
        • Recruiting
        • Phoebe Putney Memorial Hospital
        • Contact:
          • Cathy Shoemaker, OCN CBCN
          • Phone Number: 229-312-0354
      • Atlanta, Georgia, United States
        • Recruiting
        • Emory University
        • Contact:
      • Augusta, Georgia, United States
        • Recruiting
        • Augusta University Research Institute
        • Contact:
      • Dublin, Georgia, United States
        • Recruiting
        • Cancer Center of Middle Georgia
        • Contact:
    • Illinois
      • Hinsdale, Illinois, United States
        • Recruiting
        • Hope and Healing Cancer Services
        • Contact:
    • Louisiana
      • Alexandria, Louisiana, United States
      • New Orleans, Louisiana, United States
        • Recruiting
        • Tulane University
        • Contact:
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
        • Recruiting
        • Mercy Medical Center
        • Contact:
      • Baltimore, Maryland, United States
    • Mississippi
      • Hattiesburg, Mississippi, United States
      • Jackson, Mississippi, United States
      • Jackson, Mississippi, United States
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
    • New Jersey
      • Sparta, New Jersey, United States
        • Recruiting
        • ObjectiveHealth - Premier Health Research
        • Contact:
    • New Mexico
      • Santa Fe, New Mexico, United States
        • Recruiting
        • CHRISTUS - St. Vincent Regional Cancer Center
        • Contact:
    • New York
      • Potsdam, New York, United States
      • Ridge, New York, United States
        • Recruiting
        • National Translational Research Group
        • Contact:
    • North Dakota
      • Grand Forks, North Dakota, United States
        • Recruiting
        • Altru Health System
        • Contact:
    • Ohio
      • Boardman, Ohio, United States
        • Recruiting
        • NEO Urology Associates
        • Contact:
      • Cleveland, Ohio, United States
        • Recruiting
        • Great Lakes Medical Research
        • Contact:
    • Oregon
      • Bend, Oregon, United States
    • South Carolina
      • Charleston, South Carolina, United States
        • Recruiting
        • Clinical Biotechnology Research Institute at RSFH
        • Contact:
      • Spartanburg, South Carolina, United States
        • Recruiting
        • Spartanburg Regional Health Services
        • Contact:
    • Tennessee
      • Germantown, Tennessee, United States
        • Recruiting
        • West Cancer Center
        • Contact:
    • Texas
      • Amarillo, Texas, United States
      • Texarkana, Texas, United States
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • CAMC Clinical Trials
        • Contact:
    • Wisconsin
      • Janesville, Wisconsin, United States
        • Recruiting
        • Mercy Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers as well as those with a known disease state or condition

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
Advanced Stage Cancer Collection
Donor samples derived from individuals with advanced stage cancer.
Minimal Residual Disease Collection
Donor samples obtained from individuals with a history of malignancy who are currently free of active disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data.
Time Frame: 35 years
Retention of biospecimen samples with DNA
35 years
Implement release of specimens from biorepository for testing
Time Frame: 35 years
Research for the purposes of cancer laboratory diagnostic tests.
35 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laboratory testing
Time Frame: 35 years
DNA and RNA microarray
35 years
Laboratory testing
Time Frame: 35 years
Immunohistochemistry
35 years
Laboratory testing
Time Frame: 35 years
Gene and protein expression, proteomics and matabolomics
35 years
Laboratory testing
Time Frame: 35 years
Mutation analysis
35 years
Laboratory testing
Time Frame: 35 years
Experiemental lab testing for development of new diagnostic technology
35 years
Laboratory testing
Time Frame: 35 years
Microvesicle discovery, characterization and validation.
35 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caris Science, Inc.

Investigators

  • Principal Investigator: Matthew Oberley, MD, Caris Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2035

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimated)

December 26, 2011

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCBIO-001-0710

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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