Caris Biorepository Research Protocol

• ClinicalTrials.gov Identifier: NCT01499394
• Recruitment Status: Recruiting
• First Posted: December 26, 2011
• Last Update Posted: January 23, 2020
• Sponsor: Caris Science, Inc.
• 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

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

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