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Completed

NCT Number: NCT05754658

African Cancer Genome: GMD

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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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of care

Other

Drugs routinely administered for breast cancer per local standard.

Primary outcomes

  1. Immunohistochemistry

    Time frame: Year 1-2

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

  2. Germline Mutations

    Time frame: Year 1-2

    Hereditary mutations in germline DND from breast and prostate

  3. Mutational Landscape

    Time frame: Year 2

    tumor mutation burden in breast and prostate tissues

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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