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African Cancer Genome: GMD

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05754658
Enrollment
854
Registered
2023-03-06
Start date
2022-11-28
Completion date
2026-07-10
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Prostate Cancer

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.

Interventions

OTHERStandard of Care

Drugs routinely administered for breast cancer per local standard.

Sponsors

Fox Chase Cancer Center
Lead SponsorOTHER
University of Miami Sylvester Comprehensive Cancer Center
CollaboratorOTHER
Pfizer
CollaboratorINDUSTRY
The University of The West Indies
CollaboratorOTHER
Kenya Medical Research Institute
CollaboratorOTHER
University of Nairobi, Kenya
CollaboratorUNKNOWN
University of Abomey Calavi, Benin
CollaboratorUNKNOWN
Innovating Health International, Haiti
CollaboratorUNKNOWN
Institut de Recherche en Sciences de la Sante, Burkina Faso
CollaboratorOTHER_GOV
Ministry of Health and Social Services, Namibia
CollaboratorOTHER_GOV
Morgan State University
CollaboratorOTHER
University of Alabama, Tuscaloosa
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ImmunohistochemistryYear 1-2ER, PR, Her2 and AR status in breast and prostate tissues
Germline MutationsYear 1-2Hereditary mutations in germline DND from breast and prostate
Mutational LandscapeYear 2tumor mutation burden in breast and prostate tissues

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026