Clinical Trial

African Cancer Genome: GMD

Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
critical Trial completed 2026-07-31
notable Enrollment reduced: 1500 -> 854 participants 2026-07-31
notable Primary completion pushed: 2025-12-31 -> 2026-07-10 2026-07-31
minor Completion pushed: 2025-12-31 -> 2026-07-10 2026-07-31
Trial Details
NCT Number NCT05754658
Lead Sponsor Fox Chase Cancer Center
Collaborators: University of Miami Sylvester Comprehensive Cancer Center, Pfizer, The University of The West Indies, Kenya Medical Research Institute, University of Nairobi, Kenya, University of Abomey Calavi, Benin, Innovating Health International, Haiti, Institut de Recherche en Sciences de la Sante, Burkina Faso, Ministry of Health and Social Services, Namibia, Morgan State University, University of Alabama, Tuscaloosa
Conditions Breast Cancer, Prostate Cancer
Enrollment 854 participants
Start Date 2022-11-28
Primary Completion 2026-07-10 (estimated)
Study Completion 2026-07-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-30