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NCT Number: NCT03977402

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.

Recruiting

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Key information

Conditions

Cancer Cancer Risk Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87102, United States

Location status: Recruiting

Location contact

Leslie Andritsos, MD

PRINCIPAL_INVESTIGATOR

Leslie Byatt

CONTACT

[email protected]

About this study

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.

Who can participate

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

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

Treatment and study plan

Biological specimen collection

Other

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 names: Medical chart review

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

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

Christine Serway, PhD

CONTACT

[email protected]

505-272-2412

Ellen Wojcik, MBA-HCM

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

New Mexico Cancer Research Alliance

Other

Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute
  • Ohio State University Comprehensive Cancer Center

Registry information

Official study title

INST UNM 1521: Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer

Acronym: TCCP

Important dates

Study start
2016
Primary completion
2036
Study completion
2037
First posted
Jun 6, 2019
Registry last updated
May 22, 2025

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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