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Caris Biorepository Research Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01499394
Recruitment Status : Recruiting
First Posted : December 26, 2011
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Caris Science, Inc.

Study Description
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Brief 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.


Condition or disease
Cancer

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 Design
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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Caris Biorepository Research Protocol
Study Start Date : November 2010
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2025
Groups and Cohorts
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Group/Cohort
Normal
Donor samples reflective of a "normal" non-disease state
Disease state or condition
Donor samples reflective of a known disease state or condition


Outcome Measures
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Primary Outcome Measures :
  1. Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data. [ Time Frame: 5 years ]
    Retention of biospecimen samples with DNA

  2. Implement release of specimens from biorepository for testing [ Time Frame: 5 years ]
    Research for the purposes of cancer laboratory diagnostic tests.


Secondary Outcome Measures :
  1. Laboratory testing [ Time Frame: 5 years ]
    DNA and RNA microarray

  2. Laboratory testing [ Time Frame: 5 years ]
    Immunohistochemistry

  3. Laboratory testing [ Time Frame: 5 years ]
    Gene and protein expression, proteomics and matabolomics

  4. Laboratory testing [ Time Frame: 5 years ]
    Mutation analysis

  5. Laboratory testing [ Time Frame: 5 years ]
    Experiemental lab testing for development of new diagnostic technology

  6. Laboratory testing [ Time Frame: 5 years ]
    Microvesicle discovery, characterization and validation.


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

Eligibility Criteria
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Information from the National Library of Medicine

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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499394


Contacts
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Contact: Mary Baker carisresearch@carisls.com

Locations
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United States, Georgia
Phoebe Putney Memorial Hospital Recruiting
Albany, Georgia, United States, 31701
Contact: Cathy Shoemaker, OCN CBCN    229-312-0354      
United States, Iowa
The Iowa Clinic, PC Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Mary Lepic    515-875-9815      
United States, North Carolina
Eastern Carolina Women's Center Recruiting
New Bern, North Carolina, United States, 28562
Contact: Amanda Wynne, BS, CCRC    252-633-3942      
United States, Tennessee
Advantage Clinical Research Recruiting
Nashville, Tennessee, United States, 37203
Contact: Kristie Appleton       kristie@nashvillebreastcenter.com   
United States, Washington
Overlake Hospital Recruiting
Bellevue, Washington, United States, 98004
Contact: Marj Medina, RN CCM BAN    425-467-3986      
Walla Walla Clinic Recruiting
Walla Walla, Washington, United States, 99362
Contact: Lauri McKinley       Lauri.McKinley@wallawallaclinic.com   
United States, West Virginia
CAMC Clinical Trials Recruiting
Charleston, West Virginia, United States, 25304
Contact: Kristi Sutphin    304-388-9945    kristi.sutphin@CAMC.org   
Sponsors and Collaborators
Caris Science, Inc.
Investigators
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Principal Investigator: Zoran Gatalica, MD, DSc Caris Life Sciences
More Information
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Responsible Party: Caris Science, Inc.
ClinicalTrials.gov Identifier: NCT01499394    
Other Study ID Numbers: TCBIO-001-0710
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020