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Morehouse Total Cancer Care Protocol (MSMTCC)

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ClinicalTrials.gov Identifier: NCT04804878
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
James Lillard, PhD, Morehouse School of Medicine

Study Description
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Brief Summary:
The overall objective of the Morehouse Total Cancer Care study is to develop an improved standard of cancer care by facilitating new biomarker and drug target discovery, informatics solutions, clinical trials, and "personalized medicine" for our community oncology partners (i.e., community hospital systems, and other cancer care providers). To bring new translational research to the community, Morehouse School of Medicine has initiated the 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 African American cancer patients, survivors, or those at risk of having cancer. This is not a treatment trial, but a longitudinal study designed to create a centralized cancer biorepository for precision medicine.

Condition or disease Intervention/treatment
Cancer Cancer Risk Procedure: Collection of blood, tissue, and other biological samples. Other: Medical Chart Review

Detailed Description:
Through this protocol, Morehouse School of Medicine 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, investigators require an informed consent 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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Morehouse Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : April 2035
Estimated Study Completion Date : April 2037
Groups and Cohorts
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Group/Cohort Intervention/treatment
Biospeciman Repository and Data Collection
Patients with cancer or who are at risk of having cancer who have given consent to have blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected and stored for the advancement of medicine.
 Procedure: Collection of blood, tissue, and other biological samples.
Behavioral health assessments, including quality of life.
Other Name: Surveys

Other: Medical Chart Review
Health data abstracted directly from patient's health records


Outcome Measures
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Primary Outcome Measures :
  1. Improve Standard of Cancer Care [ Time Frame: Time Frame: up to 20 years ]
    Establish a longitudinal clinical and related data and tissue repository that will contain cancer predisposing risk factors via surveys and questionnaires.

  2. Improve Standard of Cancer Care [ Time Frame: Time Frame: up to 20 years ]
    Establish a longitudinal clinical and related data repository that will contain quality of life care via surveys and questionnaires

  3. Improve Standard of Cancer Care [ Time Frame: Time Frame: up to 20 years ]
    Establish a longitudinal tissue repository that will contain blood, tissue, and other biological samples other biological samples and associated clinical data collected from consenting patients.


Biospecimen Retention:   Samples With DNA
Biospecimens collected under TCC protocol can include excess tissue, fluid or blood removed during a clinical procedure, tissue collected as part of clinical care, and research specific collection. Other biological samples, such as saliva, sputum, urine, feces, hair, surface skin swabs, etc., may be collected as part of the TCCP if the collection meets criteria for minimal risk and/or is part of the patient's routine standard of care.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  1. 18 years of age and older.
  2. Diagnosed with cancer, or at risk for cancer. This includes anyone in the general population, but our primary focus will be on patients with a cancer diagnosis.
  3. Able to understand and sign the TCCP Informed Consent and Research Authorization form directly or through an authorized representative. The Informed Consent and Research Authorization will be available in both English and Spanish languages

Exclusion Criteria:

None

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Contacts and Locations
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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): NCT04804878


Contacts
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Contact: LaTrisha Horne 404-752-1034 totalcancercare@msm.edu

Locations
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United States, Georgia
Morehouse School of Medicine Recruiting
Atlanta, Georgia, United States, 30310
Contact: Margaret Hooker    404-752-1034    mhooker@msm.edu   
Sponsors and Collaborators
Morehouse School of Medicine
Investigators
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Principal Investigator: James W Lillard, PhD Morehouse School of Medicine
More Information
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Responsible Party: James Lillard, PhD, Professor of Microbiology, Biochemistry, & Immunology, Morehouse School of Medicine
ClinicalTrials.gov Identifier: NCT04804878    
Other Study ID Numbers: 841718
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021

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