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NCT Number: NCT01499394

Caris Biorepository Research Protocol

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Alabama, Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data.

    Time frame: 35 years

    Retention of biospecimen samples with DNA

  2. Implement release of specimens from biorepository for testing

    Time frame: 35 years

    Research for the purposes of cancer laboratory diagnostic tests.

Secondary outcomes

  1. Laboratory testing

    Time frame: 35 years

    DNA and RNA microarray

  2. Laboratory testing

    Time frame: 35 years

    Immunohistochemistry

  3. Laboratory testing

    Time frame: 35 years

    Gene and protein expression, proteomics and matabolomics

  4. Laboratory testing

    Time frame: 35 years

    Mutation analysis

  5. Laboratory testing

    Time frame: 35 years

    Experiemental lab testing for development of new diagnostic technology

  6. Laboratory testing

    Time frame: 35 years

    Microvesicle discovery, characterization and validation.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Baker

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Caris Science, Inc.

Industry

Registry information

Official study title

The Caris Biorepository Research Protocol

Important dates

Study start
2010
Primary completion
2030
Study completion
2035
First posted
Dec 26, 2011
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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