African Cancer Genome: GMD

NCT05754658 | Recruiting

• 1 other identifier: 22-4004
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop a comprehensive characterization of genetic and molecular drivers of breast and prostate cancer in individuals of African ancestry. The study is conducted by the African Caribbean Cancer Consortium (AC3) and involves the recruitment of patients from nine international AC3 research sites in the Bahamas, Barbados, Benin, Burkina Faso, Haiti, Jamaica, Kenya, Namibia, and Trinidad and Tobago, and the US. The main questions are to: molecularly characterize genomic changes in the African Cancer genomes of the breast and prostate and identify the effects of social determinants of health and lifestyle factors on mutational landscape. Black individuals that have been diagnosed with pathologically confirmed prostate or breast cancer will be included. Detailed social determinants of health survey, blood and archived FFPE tissues will be collected. (Tier 1) All patient tissues will be subject to IHC for receptor status (ER, AR, PR Her2/neu). All patients with available germline DNA from blood will receive genetic screening using a Commercial gene panel testing. (Tier 2) Patient samples with a negative genetic screening will be subject to whole exome sequencing or banked for later RNA or methylation sequencing.

Conditions

Breast Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Immunohistochemistry

  ER, PR, Her2 and AR status in breast and prostate tissues

  Year 1-2

• Germline Mutations

  Hereditary mutations in germline DND from breast and prostate

  Year 1-2

• Mutational Landscape

  tumor mutation burden in breast and prostate tissues

  Year 2

Study Arms (2)

Breast Cancer

Female patients

Other: Standard of Care

Prostate Cancer

Male patients

Other: Standard of Care

Interventions

Standard of Care OTHER

Drugs routinely administered for breast cancer per local standard.

Breast Cancer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females who self-identify as Black with a pathologically confirmed diagnosis of prostate or breast cancer are eligible for this study.

You may qualify if:

• Male or female patients, 18-85 years of age, diagnosed with a pathologically confirmed cancer at any stage at diagnosis. Participant can have a history of a previous cancer we will control for previous history of cancer diagnosis in our analysis.

You may not qualify if:

• Patients age \<18 year, incarcerated patients, and patients whose medical decisions are made by proxy will be excluded.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• University of Miami Sylvester Comprehensive Cancer Center: collaborator
• Pfizer: collaborator
• The University of The West Indies, Mona, Jamaica: collaborator
• Kenya Medical Research Institute: collaborator
• University of Nairobi, Kenya: collaborator
• University of Abomey Calavi, Benin: collaborator
• Innovating Health International, Haiti: collaborator
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• The University of the West Indies at Cave Hill, Barbados: collaborator
• The University of The West Indies School of Clinical Medicine and Research, The Bahamas: collaborator
• Ministry of Health and Social Services, Namibia: collaborator
• Morgan State University: collaborator
• University of Alabama, Tuscaloosa: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and FFPE samples for DNA and RNA extraction

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Camille Ragin, PhD, MPH

CONTACT

215-728-1148; Camille.Ragin@fccc.edu

Sophia George, PhD

CONTACT

sophia.george@med.miami.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 6, 2023
• Study Start: November 28, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-08

Locations

US (1)