African Cancer Genome: GMD

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Prostate Cancer

Intervention / Treatment
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* Other: Standard of Care
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer<br>Female patients | Other: Standard of Care<br>* Drugs routinely administered for breast cancer per local standard.<br>|
| Prostate Cancer<br>Male patients | Other: Standard of Care<br>* Drugs routinely administered for prostate cancer per local standard.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemistry | ER, PR, Her2 and AR status in breast and prostate tissues | Year 1-2 | 
| Germline Mutations | Hereditary mutations in germline DND from breast and prostate | Year 1-2 | 
| Mutational Landscape | tumor mutation burden in breast and prostate tissues | Year 2 |