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

Study Overview
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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.

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

Conditions
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Cancer, Cancer Risk

Intervention / Treatment
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* Other: Biological specimen collection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |