Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer (TCCP)
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ClinicalTrials.gov Identifier: NCT03977402 |
Recruitment Status :
Recruiting
First Posted : June 6, 2019
Last Update Posted : October 5, 2022
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Condition or disease | Intervention/treatment |
---|---|
Cancer Cancer Risk | Other: Biological specimen collection |
Study Type : | Observational |
Estimated Enrollment : | 47500 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | INST UNM 1521: Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer |
Actual Study Start Date : | January 27, 2016 |
Estimated Primary Completion Date : | December 31, 2036 |
Estimated Study Completion Date : | December 31, 2037 |
- Other: Biological specimen collection
Collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from patients with cancer or at risk of having cancer. This is not a treatment trial. It is a study designed to create a centralized data and tissue repository.Other Name: Medical chart review
- Amount of clinical patient demographic data collected for a repository linked to clinical data for long-term research use. [ Time Frame: up to 20 years ]Establish a longitudinal clinical data repository that will contain information about patient demographics collected via surveys and questionnaires.
- Amount of clinical patient medical treatment and outcome data collected via medical histories for long-term research use [ Time Frame: up to 20 years ]Establish a longitudinal clinical data repository that will contain information about medical treatments and patient outcomes collected via medical chart review and patient medical histories.
- Number of biospecimens collected for a tissue repository linked to clinical data for long-term research use [ Time Frame: up to 20 years ]Establish a longitudinal tissue repository that will contain tissues (blood, tumor tissue) and other biological samples and associated clinical data collected from consenting patients.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 18 years of age and older.
- Has a diagnosis of cancer or is suspected of having cancer.
- Able to understand and sign the Informed Consent form directly.
- Pregnant women are permitted to be enrolled.
Exclusion Criteria:
- Prisoners

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977402
Contact: Christine Serway, PhD | 505-272-2412 | CSerway@salud.unm.edu | |
Contact: Ellen Wojcik, MBA-HCM | ewojcik@salud.unm.edu |
United States, New Mexico | |
University of New Mexico Comprehensive Cancer Center | Recruiting |
Albuquerque, New Mexico, United States, 87102 | |
Contact: Leslie Byatt lpbyatt@salud.unm.edu | |
Principal Investigator: Leslie Andritsos, MD |
Principal Investigator: | Leslie Andritsos, MD | University of New Mexico Cancer Center |
Responsible Party: | New Mexico Cancer Care Alliance |
ClinicalTrials.gov Identifier: | NCT03977402 |
Other Study ID Numbers: |
INST UNM 1521 |
First Posted: | June 6, 2019 Key Record Dates |
Last Update Posted: | October 5, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | As an ORIEN member institution, UNMCCC will share limited data with the ORIEN consortium, including patient identifiers, collected from patients with known or suspected cancer. UNMCCC may also distribute any blood, tissue samples, or other biological samples with protected health information according to the Information Warehouse (IW) TCCP honest broker policy and UNM Human Tissue Repository (HTR). |
Time Frame: | Unknown at this time |
Access Criteria: | ORIEN consortium membership |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |