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Caris Biorepository Research Protocol

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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.

Tracking Information
First Submitted Date December 16, 2011
First Posted Date December 26, 2011
Last Update Posted Date January 23, 2020
Study Start Date November 2010
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 22, 2011)
  • 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
  • Implement release of specimens from biorepository for testing [ Time Frame: 5 years ]
    Research for the purposes of cancer laboratory diagnostic tests.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 22, 2011)
  • Laboratory testing [ Time Frame: 5 years ]
    DNA and RNA microarray
  • Laboratory testing [ Time Frame: 5 years ]
    Immunohistochemistry
  • Laboratory testing [ Time Frame: 5 years ]
    Gene and protein expression, proteomics and matabolomics
  • Laboratory testing [ Time Frame: 5 years ]
    Mutation analysis
  • Laboratory testing [ Time Frame: 5 years ]
    Experiemental lab testing for development of new diagnostic technology
  • Laboratory testing [ Time Frame: 5 years ]
    Microvesicle discovery, characterization and validation.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Caris Biorepository Research Protocol
Official Title The Caris Biorepository Research Protocol
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Currently plasma with an opportunity to collect other biospecimens
Sampling Method Non-Probability Sample
Study Population Healthy volunteers as well as those with a known disease state or condition
Condition Cancer
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 22, 2011)
100000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2025
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mary Baker carisresearch@carisls.com
Listed Location Countries United States
Removed Location Countries Canada
 
Administrative Information
NCT Number NCT01499394
Other Study ID Numbers TCBIO-001-0710
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Caris Science, Inc.
Study Sponsor Caris Science, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Zoran Gatalica, MD, DSc Caris Life Sciences
PRS Account Caris Science, Inc.
Verification Date January 2020