Morehouse Total Cancer Care Protocol (MSMTCC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Cancer Risk
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: LaTrisha Horne; Phone Number: 404-752-1034; Email: totalcancercare@msm.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30310
      • Recruiting
      • Morehouse School of Medicine
      • Contact: Margaret Hooker; Phone Number: 404-752-1034; Email: mhooker@msm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders 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.

Description

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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Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve Standard of Cancer Care	Establish a longitudinal clinical and related data and tissue repository that will contain cancer predisposing risk factors via surveys and questionnaires.	Time Frame: up to 20 years
Improve Standard of Cancer Care	Establish a longitudinal clinical and related data repository that will contain quality of life care via surveys and questionnaires	Time Frame: up to 20 years
Improve Standard of Cancer Care	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.	Time Frame: up to 20 years

Collaborators and Investigators

• Sponsor: Morehouse School of Medicine
• Investigators: Principal Investigator: James W Lillard, PhD, Morehouse School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Anticipated): April 1, 2035
• Study Completion (Anticipated): April 1, 2037

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 841718

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No