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CompletedNCT05754658Updated Jul 30, 2026

African Cancer Genome: GMD

An observational study in Breast Cancer and Prostate Cancer, sponsored by Fox Chase Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Fox Chase Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
854
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Breast Cancer
  • Prostate Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 854 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
854 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Breast Cancer

    Female patients

    Other: Standard of Care

  • Prostate Cancer

    Male patients

    Other: Standard of Care

Interventions

  • OtherStandard of Care

    Drugs routinely administered for breast cancer per local standard.

  • OtherStandard of Care

    Drugs routinely administered for prostate cancer per local standard.

06

What researchers measure

Primary outcomes

  1. Immunohistochemistry

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

    Time frame: Year 1-2

  2. Germline Mutations

    Hereditary mutations in germline DND from breast and prostate

    Time frame: Year 1-2

  3. Mutational Landscape

    tumor mutation burden in breast and prostate tissues

    Time frame: Year 2

07

Study locations

1 site
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
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
Responsible party
Camille Ragin, PhD, MPH (Professor, Fox Chase Cancer Center) — Principal investigator
First posted
Mar 6, 2023
Start date
Nov 28, 2022
Primary completion
Jul 10, 2026
Completion
Jul 10, 2026
Last update
Jul 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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