African Cancer Genome: GMD

Clinicaltrials.gov ID: NCT05754658
db-list-check Status RECRUITING
b-loader Phase
b-people Age 18 - 85 Years
b-bullseye-arrow Enrollments 1500

Conditions

Breast Cancer, Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Eligibility Criteria

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

Breast Cancer

Female patients

  • OTHER:

    Standard of Care

    Description:

    Drugs routinely administered for breast cancer per local standard.

Prostate Cancer

Male patients

  • OTHER:

    Standard of Care

    Description:

    Drugs routinely administered for prostate cancer per local standard.

Outcome Measures

Primary Outcome Measures

Immunohistochemistry

Time Frame: Year 1-2

Germline Mutations

Time Frame: Year 1-2

Mutational Landscape

Time Frame: Year 2

Timeline

  • Last Updated
    March 27, 2023
  • Start Date
    March 6, 2023
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    July 1, 2024

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