Caris Biorepository Research Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer, Early Detection of Cancer, Minimal Residual Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Caris Biorepository Research Protocol
Overview
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.
Primary outcome measures
- Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data. [Time frame: 35 years]
- Implement release of specimens from biorepository for testing [Time frame: 35 years]
Secondary outcome measures (6)
- Laboratory testing [Time frame: 35 years]
- Laboratory testing [Time frame: 35 years]
- Laboratory testing [Time frame: 35 years]
- Laboratory testing [Time frame: 35 years]
- Laboratory testing [Time frame: 35 years]
- Laboratory testing [Time frame: 35 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 38 centers
- University of South Alabama — Mobile
- Southwest Medical Imaging — Scottsdale
- St. Bernards Medical Center — Jonesboro
- CARTI Cancer Center — Little Rock
- ObjectiveHealth - ARcare Center for Clinical Research — Little Rock
- Lee Memorial Health System — Fort Myers
- Cancer Care of North Florida — Lake City
- Advent Health — Orlando
- … and 30 more centers
Identifiers
NCT: NCT01499394 · TCBIO-001-0710