Caris Biorepository Research Protocol

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.

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