Clinical trial NCT01499394: Caris Biorepository Research Protocol
Official title: The Caris Biorepository Research Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Caris Science, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers as well as those with a known disease state or condition

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.

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

Primary outcomes:
measure: Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data.
timeFrame: 5 years
measure: Implement release of specimens from biorepository for testing
timeFrame: 5 years
Secondary outcomes:
measure: Laboratory testing
timeFrame: 5 years
measure: Laboratory testing
timeFrame: 5 years
measure: Laboratory testing
timeFrame: 5 years
measure: Laboratory testing
timeFrame: 5 years
measure: Laboratory testing
timeFrame: 5 years
measure: Laboratory testing
timeFrame: 5 years
Other outcomes:
Locations:
city: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: West Des Moines
country: United States
facility: The Iowa Clinic, PC
state: Iowa
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Nashville
country: United States
facility: Advantage Clinical Research
state: Tennessee
city: Bellevue
country: United States
facility: Overlake Hospital
state: Washington
city: Walla Walla
country: United States
facility: Walla Walla Clinic
state: Washington
city: Charleston
country: United States
facility: CAMC Clinical Trials
state: West Virginia
Study officials:
affiliation: Caris Life Sciences
name: Zoran Gatalica, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References: