CancerTCCPNCT03977402
Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
An observational study of Cancer and Cancer Risk, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial summary
The overall objective of this study is to ultimately develop an improved standard of cancer care by facilitating new cancer research, clinical trials, new technology, new informatics solutions, and "personalized medicine" for the University of New Mexico Comprehensive Cancer Center (UNMCCC) and the Oncology Research… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer Risk
- What is being tested?
- Biological specimen collection
- How many people
- 47,500 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2016to 31 Dec 2037
- 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
- Adult, Older adult
Study population: Patients 18 years of age or older who have cancer or are at risk of developing cancer.
Who may be able to join
- 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.
Who cannot join
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102
Cheryl Sampson, MBA, 505 272-4946, ChSampson@salud.unm.edu
Leslie Andritsos, MD
About this study
Official title: INST UNM 1521: Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
The overall objective of this study is to ultimately develop an improved standard of cancer care by facilitating new cancer research, clinical trials, new technology, new informatics solutions, and "personalized medicine" for the University of New Mexico Comprehensive Cancer Center (UNMCCC) and the Oncology Research Information Exchange Network (ORIEN) Consortium of academic medical centers, community hospital systems, and other health care providers. To bring new translational research to the community, the ORIEN consortium has initiated the ORIEN Total Cancer Care Program (TCCP). The TCCP establishes a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of 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.
Read the detailed description
Through this protocol, UNMCCC and its partners will establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer. In this protocol, the investigators require the permission of patients to study their answers to survey questions that may be collected as part of their regular clinical care, permission to study their medical and related records, and permission to collect excess tissues removed at the time of planned surgery, an additional tumor sampling (needle passes) at the time of planned diagnostic biopsies, previously collected, stored tumor tissue (if available), blood, and/or other biological samples. Additional research tumor samples may be collected at the time of any diagnostic needle biopsy or endoscopic biopsy or, if available, patient tissue from a previous procedure will be obtained and utilized as needed. Clinical and related data will be collected on all patients from the time of initial entry into the study and will continue for life.
- Conditions
- Cancer, Cancer Risk
- Being tested
- Biological specimen collection
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological specimen collectionOther
Also called Medical chart review
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of clinical patient demographic data collected for a repository linked to clinical data for long-term research use.
Establish a longitudinal clinical data repository that will contain information about patient demographics collected via surveys and questionnaires.
Measured: up to 20 years
Amount of clinical patient medical treatment and outcome data collected via medical histories for long-term research use
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.
Measured: up to 20 years
Number of biospecimens collected for a tissue repository linked to clinical data for long-term research use
Establish a longitudinal tissue repository that will contain tissues (blood, tumor tissue) and other biological samples and associated clinical data collected from consenting patients.
Measured: up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start27 Jan 2016
- Primary completion31 Dec 2036 (estimated)
- Study completion31 Dec 2037 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 47,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute, Ohio State University Comprehensive Cancer Center
- Responsible party
- Sponsor
- Investigators
- Leslie Andritsos, MD, Principal investigator, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977402
- Sponsor's protocol ID
- INST UNM 1521
- Acronym
- TCCP
- Status last verified
- Oct 2026
- First submitted
- 8 May 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INST UNM 1521: Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
- ClinicalTrials.gov ID
- NCT03977402
- Acronym / sponsor ID
- TCCP / INST UNM 1521
- Conditions
- Cancer, Cancer Risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 47,500 participants (estimated)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute, Ohio State University Comprehensive Cancer Center
- Study start
- 27 Jan 2016 (actual)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 6 Jun 2019 (actual)
- 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 overall objective of this study is to ultimately develop an improved standard of cancer care by facilitating new cancer research, clinical trials, new technology, new informatics solutions, and "personalized medicine" for the University of New Mexico Comprehensive Cancer Center (UNMCCC) and the Oncology Research Information Exchange Network (ORIEN) Consortium of academic medical centers, community hospital systems, and other health care providers. To bring new translational research to the community, the ORIEN consortium has initiated the ORIEN Total Cancer Care Program (TCCP). The TCCP establishes a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of 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.
Detailed description
Through this protocol, UNMCCC and its partners will establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer. In this protocol, the investigators require the permission of patients to study their answers to survey questions that may be collected as part of their regular clinical care, permission to study their medical and related records, and permission to collect excess tissues removed at the time of planned surgery, an additional tumor sampling (needle passes) at the time of planned diagnostic biopsies, previously collected, stored tumor tissue (if available), blood, and/or other biological samples. Additional research tumor samples may be collected at the time of any diagnostic needle biopsy or endoscopic biopsy or, if available, patient tissue from a previous procedure will be obtained and utilized as needed. Clinical and related data will be collected on all patients from the time of initial entry into the study and will continue for life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age or older who have cancer or are at risk of developing cancer.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological specimen collectionAlso: Medical chart reviewCollection 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 | – |
Primary outcome
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.
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 22 Oct 2026.
- Individual participant dataSharing planned: Yes. 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).
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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.
Leslie Andritsos, MD principal investigator
University of New Mexico Cancer Center
1 site 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 Cancer Risk, run by New Mexico Cancer Research Alliance at 1 site 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 4 inclusion and 1 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Ellen Wojcik, MBA-HCM (505 272-4946, ewojcik@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 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 22 Oct 2026.