Clinical trial NCT03977402: Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
Official title: INST UNM 1521: Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Cancer Risk
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
Collaborators: name: H. Lee Moffitt Cancer Center and Research Institute
name: Ohio State University Comprehensive Cancer Center
First posted: 2019-06-06
Enrollment: 47500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older who have cancer or are at risk of developing cancer.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amount of clinical patient demographic data collected for a repository linked to clinical data for long-term research use.
timeFrame: up to 20 years
measure: Amount of clinical patient medical treatment and outcome data collected via medical histories for long-term research use
timeFrame: up to 20 years
measure: Number of biospecimens collected for a tissue repository linked to clinical data for long-term research use
timeFrame: up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico Cancer Center
name: Leslie Andritsos, MD
role: PRINCIPAL_INVESTIGATOR
References: