African Cancer Genome: GMD

African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Prostate Cancer
• Intervention / Treatment: Other: Standard of Care; Other: Standard of Care

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: CAMILLE RAGIN, PhD, MPH; Phone Number: 215-728-1148; Email: camille.ragin@fccc.edu
• Study Contact Backup: Name: SOPHIA GEORGE, PhD; Email: Sophia.george@med.miami.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center
      • Contact: CAMILLE RAGIN, PhD, MPH; Phone Number: 215-728-1148; Email: camille.ragin@fccc.edu
      • Contact: SOPHIA GEORGE, PhD; Email: Sophia.george@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast Cancer; Female patients	Other: Standard of Care; Drugs routinely administered for breast cancer per local standard.; Other: Standard of Care; Drugs routinely administered for prostate cancer per local standard.
Prostate Cancer; Male patients	Other: Standard of Care; Drugs routinely administered for breast cancer per local standard.; Other: Standard of Care; Drugs routinely administered for prostate cancer per local standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Immunohistochemistry	ER, PR, Her2 and AR status in breast and prostate tissues	Year 1-2

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Prostatic Neoplasms; Breast Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 22-4004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No