Morehouse Total Cancer Care Protocol

Recruiting

• Conditions: Cancer; Cancer Risk
• Interventions: Procedure: Collection of blood, tissue, and other biological samples.; Other: Medical Chart Review

• Registration Number: NCT04804878
• Lead Sponsor: Morehouse School of Medicine

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.

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 Timeline

• Study Start: 2018-04-05
• Status Verified: 2021-03
• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Last Update Submitted: 2021-03-16
• Study First Posted: 2021-03-18
• Last Update Posted: 2021-03-18
• Primary Completion: 2035-04
• Study Completion: 2037-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biospeciman Repository and Data Collection	Collection of blood, tissue, and other biological samples.	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.
Biospeciman Repository and Data Collection	Medical Chart Review	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.

Primary Outcome Measures

Name	Time	Method
Improve Standard of Cancer Care	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.

Trial Locations

Locations (1)

Morehouse School of Medicine; 🇺🇸 Atlanta, Georgia, United States