Caris Biorepository Research Protocol
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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 |
|---|
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Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Caris Biorepository Research Protocol |
- 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.
- 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 |
|---|
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Normal
Donor samples reflective of a "normal" non-disease state
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Disease state or condition
Donor samples reflective of a known disease state or condition
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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 |
Healthy volunteers as well as those with a known disease state or condition
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| 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 | |
| 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 May 16, 2013