CancerNCT01499394
Caris Biorepository Research Protocol
An observational study of Cancer and Early Detection of Cancer, run by Caris Science, Inc. at 38 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Early Detection of Cancer, Minimal Residual Disease
- How many people
- 100,000 participants
- Where
- 38 sitesUnited States
- Study dates
- Nov 2010to Nov 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers as well as those with a known disease state or condition
Who may be able to join
- 18 years of age or older
- Capacity to provide informed consent
Who cannot join
- 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
Trial locations and contacts
38 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mary Baker contact
38 sites in 1 country
United States38 sites, 38 recruiting
- Recruiting
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
Cathy Shoemaker, OCN CBCN, 229-312-0354
- Recruiting
CHRISTUS - St. Frances Cabrini Hospital
Alexandria, Louisiana
Crystal Dubois, 318-528-5137, crystal.dubois2@christushealth.org
- Recruiting
ObjectiveHealth - Amarillo Premier Research
Amarillo, Texas
Lauren Kuehler, 806-641-0256, Lauren.Kuehler@objective.health
- Recruiting
Emory University
Atlanta, Georgia
Sharon Egbue-Ojirogbe, 404-778-8027, cegbueo@emory.edu
- Recruiting
Augusta University Research Institute
Augusta, Georgia
Alexander Ward, 706-721-1623, ALWARD@augusta.edu
- Recruiting
Mercy Medical Center
Baltimore, Maryland
Rhiannon Kim, 410-951-7908, rkim1@mdmercy.com
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland
Pamela Nickoles, 410-601-6120, Pnickole@lifebridgehealth.org
- Recruiting
Bend Memorial Clinic
Bend, Oregon
Madison Cox, 541-706-5339, mklinskicox@summithealth.com
- Recruiting
NEO Urology Associates
Boardman, Ohio
Tina Picino, 330-729-9214 ext. 240, tpicino@neourology.com
- Recruiting
Clinical Biotechnology Research Institute at RSFH
Charleston, South Carolina
Aindrea Maddray, 843-724-2204, Aindrea.Maddray@rsfh.com
- Recruiting
CAMC Clinical Trials
Charleston, West Virginia, 25304
Kristi Sutphin, 304-388-9945, kristi.sutphin@CAMC.org
- Recruiting
Great Lakes Medical Research
Cleveland, Ohio
Cortney Vazquez, 216-372-0505, cvazquez@thectnx.com
- Recruiting
Cancer Center of Middle Georgia
Dublin, Georgia
Audrey Bryan, 478-272-8266 ext. 321, research@ccmgeorgia.com
- Recruiting
Lee Memorial Health System
Fort Myers, Florida
Juliana Turner, 239-343-9660, juliana.turner@leehealth.org
- Recruiting
West Cancer Center
Germantown, Tennessee
Melissa Smith, 901-683-0055 ext. 62739, msmith@WESTCLINIC.com
- Recruiting
Altru Health System
Grand Forks, North Dakota
Alexis Tatum, 701-780-1563, ATATUM@altru.org
- Recruiting
Hattiesburg Clinic
Hattiesburg, Mississippi
Gloria Simmons, 601-288-2494, Gloria.Simmons@forrestgeneral.com
- Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois
Ava Baftirovska, 630 560 0121 ext. 107, abaftirovska@hopenheal.care
- Recruiting
Jackson Oncology Associates
Jackson, Mississippi
Teresa Davis, 601-974-5547, tdavis@jacksononcology.com
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi
Tanya Robinson, 601-815-2123, trobinson13@umc.edu
- Recruiting
Mercy Health
Janesville, Wisconsin
Ashli Huppert, 608-756-6695, ahuppert@mhemail.org
- Recruiting
St. Bernards Medical Center
Jonesboro, Arkansas
Dashae King, 870-207-8157, dlking@sbrmc.org
- Recruiting
Cancer Care of North Florida
Lake City, Florida
Natalie Espenship, 386-755-1655, Natalie.Espenship@cancercareofnorthflorida.com
- Recruiting
CARTI Cancer Center
Little Rock, Arkansas
Jesse Byrd, 501-561-2205, Jesse.Byrd@Carti.com
- Recruiting
ObjectiveHealth - ARcare Center for Clinical Research
Little Rock, Arkansas
Cynthia Whitcomb, 501-214-0372, Cynthia.Whitcomb@objective.health
- Recruiting
University of South Alabama
Mobile, Alabama
Tiffany Fulford, 251-445-3276, tnfulford@health.southalabama.edu
- Recruiting
Tulane University
New Orleans, Louisiana
Priya Bhandari, 504-988-6053, pbhandari@tulane.edu
- Recruiting
Advent Health
Orlando, Florida
Corina Mattix, 407-303-1327, Corina.Mattix@AdventHealth.com
- Recruiting
St. Lawrence Health System
Potsdam, New York
McKenna Boula, 315-261-6319, McKenna.Boula@rochesterregional.org
- Recruiting
National Translational Research Group
Ridge, New York
Stella Smaragdas, 631-675-5103, ssmaragdas@nycancer.com
- Recruiting
CHRISTUS - St. Vincent Regional Cancer Center
Santa Fe, New Mexico
MiQuela Gutierrez, 505-913-8822, Miquela.Gutierrez@stvin.org
- Recruiting
Southwest Medical Imaging
Scottsdale, Arizona
Emily Crampton, 480-425-4055, ECrampton@esmil.com
- Recruiting
CHRISTUS - Highland Medical Center
Shreveport, Louisiana
Thea Spencer, 318-681-6007, thea.spencer@christushealth.org
- Recruiting
ObjectiveHealth - Premier Health Research
Sparta, New Jersey
Lori Walsh, 862-294-0418, Lori.Walsh@objective.health
- Recruiting
Spartanburg Regional Health Services
Spartanburg, South Carolina
Kamara Mertz-Rivera, 864-560-6104, kmertz-Rivera@gibbscc.org
- Recruiting
The University of South Florida
Tampa, Florida
Brittney Short, 727-612-4026, bborresen@tgh.org
- Recruiting
CHRISTUS - St. Michael's Health
Texarkana, Texas
Kimberly Everett, 903-614-6885, kimberly.everett@christushealth.org
- Recruiting
Cleveland Clinic Florida
Weston, Florida
Brianna Hammond, 954-487-2257, HAMMONB7@ccf.org
About this study
Official title: The 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.
Read the 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.
- Conditions
- Cancer, Early Detection of Cancer, Minimal Residual Disease
- Keywords
- Caris Biorepository, MCED, Early Detection, MRD, Pan-Cancer
- Medical subject headings
- Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Donor samples reflective of a "normal" non-disease state | |
| Newly Diagnosed Pan-Cancer Collection | Donor samples derived from treatment naïve patients with newly diagnosed solid tumors. | |
| Early Detection Collection | Donor samples reflective of a population at increased risk for developing cancer. | |
| Advanced Stage Cancer Collection | Donor samples derived from individuals with advanced stage cancer. | |
| Minimal Residual Disease Collection | Donor samples obtained from individuals with a history of malignancy who are currently free of active disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data.
Retention of biospecimen samples with DNA
Measured: 35 years
Implement release of specimens from biorepository for testing
Research for the purposes of cancer laboratory diagnostic tests.
Measured: 35 years
Secondary outcomes (6)
Laboratory testing
DNA and RNA microarray
Measured: 35 years
Laboratory testing
Immunohistochemistry
Measured: 35 years
Laboratory testing
Gene and protein expression, proteomics and matabolomics
Measured: 35 years
Laboratory testing
Mutation analysis
Measured: 35 years
Laboratory testing
Experiemental lab testing for development of new diagnostic technology
Measured: 35 years
Laboratory testing
Microvesicle discovery, characterization and validation.
Measured: 35 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2030 (estimated)
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caris Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Oberley, MD, Principal investigator, Caris Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499394
- Sponsor's protocol ID
- TCBIO-001-0710
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2011
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Caris Biorepository Research Protocol
- ClinicalTrials.gov ID
- NCT01499394
- Acronym / sponsor ID
- TCBIO-001-0710
- Conditions
- Cancer, Early Detection of Cancer, Minimal Residual Disease
- Keywords
- Caris Biorepository, MCED, Early Detection, MRD, Pan-Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Caris Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2035 (estimated)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –Donor samples reflective of a "normal" non-disease state |
| Newly Diagnosed Pan-Cancer Collection | – | –Donor samples derived from treatment naïve patients with newly diagnosed solid tumors. |
| Early Detection Collection | – | –Donor samples reflective of a population at increased risk for developing cancer. |
| Advanced Stage Cancer Collection | – | –Donor samples derived from individuals with advanced stage cancer. |
| Minimal Residual Disease Collection | – | –Donor samples obtained from individuals with a history of malignancy who are currently free of active disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers as well as those with a known disease state or condition
Key inclusion criteria (2 listed)
- 18 years of age or older
- Capacity to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Implement release of specimens from biorepository for testing
Time frame: 35 years
Research for the purposes of cancer laboratory diagnostic tests.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Baker contact
Matthew Oberley, MD principal investigator
Caris Life Sciences
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Early Detection of Cancer, run by Caris Science, Inc. at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Baker (carisresearch@carisls.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data. (time frame: 35 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.