Trial record 1 of 1 for:    01499394
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Caris Biorepository Research Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Caris Science, Inc.
Sponsor:
Information provided by (Responsible Party):
Caris Science, Inc.
ClinicalTrials.gov Identifier:
NCT01499394
First received: December 16, 2011
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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
Cancer

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

Resource links provided by NLM:


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 ]
    Immunohistochemistry

  • 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 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

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
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 ClinicalTrials.gov identifier: NCT01499394

Locations
United States, Arizona
Banner Health Recruiting
Phoenix, Arizona, United States, 85006
Contact: Mattie Wheeler    602-839-0423    mattie.brookswheeler@bannerhealth.com   
United States, California
John Muir Clinical Research Center Recruiting
Concord, California, United States, 94520
Contact: Shelia Marquez, RN BSN    925-674-2580      
Breastlink Medical Group Recruiting
Orange, California, United States, 92868
Contact: Deidre Flores    562-981-6101 ext 118    dflores@breastlink.com   
United States, Colorado
Poudre Valley Hospital Recruiting
Fort Collins, Colorado, United States, 80528
Contact: Joanne O'Malia    970-297-6153      
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Susanne Morrill, MS, CCRP    860-545-1588      
United States, Florida
Palm Beach Cancer Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Kelly De'Dra    561-472-1698      
United States, Georgia
Phoebe Putney Memorial Hospital Recruiting
Albany, Georgia, United States, 31701
Contact: Cathy Shoemaker, OCN CBCN    229-312-0354      
United States, Indiana
Community Cancer Research Foundation Recruiting
Munster, Indiana, United States, 46321
Contact: Amber Kindt, RN BSN OCN    219-836-6875      
United States, Iowa
The Iowa Clinic, PC Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Mary Lepic    515-875-9815      
United States, Nevada
Renown Health Recruiting
Reno, Nevada, United States, 89502
Contact: Maureen Martinez, CRA    775-982-5050      
United States, North Carolina
Comprehensive Cancer Center of Pardee Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: Kristy Capps, BSN CBPC-IC    828-698-7334      
Eastern Carolina Women's Center Recruiting
New Bern, North Carolina, United States, 28562
Contact: Amanda Wynne, BS, CCRC    252-633-3942      
United States, Oregon
Bend Memorial Clinic Recruiting
Bend, Oregon, United States, 97701
Contact: Christine Reed, CCRC    541-318-3137      
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Leighanne Hartman, RN CRCII    610-402-9341      
United States, Washington
Overlake Hospital Recruiting
Bellevue, Washington, United States, 98004
Contact: Marj Medina, RN CCM BAN    425-467-3986      
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
Principal Investigator: Les Paul, MD Caris Science, Inc.
  More Information

No publications provided

Responsible Party: Caris Science, Inc.
ClinicalTrials.gov Identifier: NCT01499394     History of Changes
Other Study ID Numbers: TCBIO-001-0710
Study First Received: December 16, 2011
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014