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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03977402
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : January 10, 2020
Sponsor:
Collaborators:
H. Lee Moffitt Cancer Center and Research Institute
Ohio State University Comprehensive Cancer Center
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

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.

Condition or disease Intervention/treatment
Cancer Cancer Risk Other: Biological specimen collection

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: INST UNM 1521: Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
Actual Study Start Date : January 27, 2016
Estimated Primary Completion Date : December 31, 2036
Estimated Study Completion Date : December 31, 2037

Intervention Details:
  • 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.
    Other Name: Medical chart review


Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years of age or older who have cancer or are at risk of developing cancer.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977402


Contacts
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Contact: Christine Serway, PhD 505-272-2412 CSerway@salud.unm.edu
Contact: Sharareh Sazesh, MS ssazesh@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico - Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Amy Overby    505-272-5557    Aoverby1@salud.unm.edu   
Principal Investigator: Leslie Andritsos, MD         
Sponsors and Collaborators
New Mexico Cancer Care Alliance
H. Lee Moffitt Cancer Center and Research Institute
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Leslie Andritsos, MD University of New Mexico Cancer Center
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Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT03977402    
Other Study ID Numbers: INST UNM 1521
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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).
Time Frame: Unknown at this time
Access Criteria: ORIEN consortium membership

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No