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

NCT ID: NCT03977402

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

47500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-27

Study Completion Date

2037-12-31

Brief Summary

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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

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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

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Cancer Cancer Risk

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Medical chart review

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role collaborator

New Mexico Cancer Research Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie Andritsos, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Cancer Center

Locations

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University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christine Serway, PhD

Role: CONTACT

505-272-2412

Ellen Wojcik, MBA-HCM

Role: CONTACT

Facility Contacts

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Leslie Byatt

Role: primary

Other Identifiers

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INST UNM 1521

Identifier Type: -

Identifier Source: org_study_id

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