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.
Conditions
- Cancer
- Early Detection of Cancer
- Minimal Residual Disease
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
| Arm | Description | Assigned Intervention |
|---|---|---|
| Normal | Donor samples reflective of a "normal" non-disease state | |
| Newly Diagnosed Pan-Cancer Collection | Donor samples derived from treatment naïve patients with newly diagnosed solid tumors. | |
| Early Detection Collection | Donor samples reflective of a population at increased risk for developing cancer. | |
| Advanced Stage Cancer Collection | Donor samples derived from individuals with advanced stage cancer. | |
| Minimal Residual Disease Collection | Donor samples obtained from individuals with a history of malignancy who are currently free of active disease |
Recruiting Locations
Mobile 4076598, Alabama 4829764
Scottsdale 5313457, Arizona 5551752
Jonesboro 4116834, Arkansas 4099753
Little Rock 4119403, Arkansas 4099753
Little Rock 4119403, Arkansas 4099753
Fort Myers 4155995, Florida 4155751
Lake City 4161187, Florida 4155751
Orlando 4167147, Florida 4155751
Tampa 4174757, Florida 4155751
Weston 4178003, Florida 4155751
Albany 4179320, Georgia 4197000 31701
Cathy Shoemaker, OCN CBCN
229-312-0354
Atlanta 4180439, Georgia 4197000
Augusta 4180531, Georgia 4197000
Dublin 4192205, Georgia 4197000
Hinsdale 4896012, Illinois 4896861
Alexandria 4314550, Louisiana 4331987
New Orleans 4335045, Louisiana 4331987
Shreveport 4341513, Louisiana 4331987
Baltimore 4347778, Maryland 4361885
Baltimore 4347778, Maryland 4361885
Hattiesburg 4429295, Mississippi 4436296
Jackson 4431410, Mississippi 4436296
Jackson 4431410, Mississippi 4436296
Sparta 5104882, New Jersey 5101760
Santa Fe 5490263, New Mexico 5481136
Potsdam 5132103, New York 5128638
Ridge 5133832, New York 5128638
Grand Forks 5059429, North Dakota 5690763
Boardman 5147784, Ohio 5165418
Cleveland 5150529, Ohio 5165418
Bend 5713587, Oregon 5744337
Charleston 4574324, South Carolina 4597040
Spartanburg 4597200, South Carolina 4597040
Germantown 4624601, Tennessee 4662168
Amarillo 5516233, Texas 4736286
Texarkana 4736096, Texas 4736286
Charleston 4801859, West Virginia 4826850 25304
Janesville 5257754, Wisconsin 5279468
More Details
- NCT ID
- NCT01499394
- Status
- Recruiting
- Sponsor
- Caris Science, Inc.
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.