Caris Biorepository Research Protocol

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Caris Biorepository Research Protocol

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal<br>Donor samples reflective of a normal non-disease state | |
| Disease state or condition<br>Donor samples reflective of a known disease state or condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data. | Retention of biospecimen samples with DNA | 5 years | 
| Implement release of specimens from biorepository for testing | Research for the purposes of cancer laboratory diagnostic tests. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory testing | DNA and RNA microarray | 5 years | 
| Laboratory testing | Immunohistochemistry | 5 years | 
| Laboratory testing | Gene and protein expression, proteomics and matabolomics | 5 years | 
| Laboratory testing | Mutation analysis | 5 years | 
| Laboratory testing | Experiemental lab testing for development of new diagnostic technology | 5 years | 
| Laboratory testing | Microvesicle discovery, characterization and validation. | 5 years |