Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
TCCP
INST UNM 1521: Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
1 other identifier
observational
47,500
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2016
CompletedFirst Submitted
Initial submission to the registry
May 8, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2037
May 22, 2025
May 1, 2025
20.9 years
May 8, 2019
May 20, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
up to 20 years
Interventions
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.
Eligibility Criteria
Patients 18 years of age or older who have cancer or are at risk of developing cancer.
You may qualify if:
- 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.
You may not qualify if:
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102, United States
Biospecimen
Excess tissue, blood and/or fluids (normal and tumor; in the form of frozen and/or formalin fixed, paraffin-embedded tissue) removed from the patient following any extirpative surgical procedure (required as part of standard medical care) for future cancer research studies.
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie Andritsos, MD
University of New Mexico Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2019
First Posted
June 6, 2019
Study Start
January 27, 2016
Primary Completion (Estimated)
December 31, 2036
Study Completion (Estimated)
December 31, 2037
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Unknown at this time
- Access Criteria
- ORIEN consortium membership
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).