Caris Biorepository Research Protocol

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Normal Donor samples reflective of a "normal" non-disease state
Disease state or condition Donor samples reflective of a known disease state or condition

Recruiting Locations

Phoebe Putney Memorial Hospital
Albany, Georgia 31701
Contact:
Cathy Shoemaker, OCN CBCN
229-312-0354

The Iowa Clinic, PC
West Des Moines, Iowa 50266
Contact:
Mary Lepic
515-875-9815

Eastern Carolina Women's Center
New Bern, North Carolina 28562
Contact:
Amanda Wynne, BS, CCRC
252-633-3942

Advantage Clinical Research
Nashville, Tennessee 37203
Contact:
Kristie Appleton
kristie@nashvillebreastcenter.com

Overlake Hospital
Bellevue, Washington 98004
Contact:
Marj Medina, RN CCM BAN
425-467-3986

Walla Walla Clinic
Walla Walla, Washington 99362
Contact:
Lauri McKinley
Lauri.McKinley@wallawallaclinic.com

CAMC Clinical Trials
Charleston, West Virginia 25304
Contact:
Kristi Sutphin
304-388-9945
kristi.sutphin@CAMC.org

More Details

NCT ID
NCT01499394
Status
Recruiting
Sponsor
Caris Science, Inc.

Study Contact

Mary Baker
carisresearch@carisls.com

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.