Morehouse Total Cancer Care Protocol

NCT04804878 | Recruiting DMC

• 1 other identifier: 841718
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Cancer Risk

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.; Other: Medical Chart Review

Interventions

Collection of blood, tissue, and other biological samples. PROCEDURE

Behavioral health assessments, including quality of life.

Also known as: Surveys

Biospeciman Repository and Data Collection

Medical Chart Review OTHER

Health data abstracted directly from patient's health records

Biospeciman Repository and Data Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age or older who have cancer or are at risk of developing cancer.

You may qualify if:

• years of age and older.
• 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.
• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Morehouse School of Medicine: lead

Study Sites (1)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

RECRUITING

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.

MeSH Terms

Conditions

Neoplasms

Interventions

Histocompatibility Testing; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• James W Lillard, PhD

  Morehouse School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LaTrisha Horne

CONTACT

404-752-1034; totalcancercare@msm.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Microbiology, Biochemistry, & Immunology

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: April 5, 2018
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): April 1, 2037
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

US (1)