About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients age <18 year, incarcerated patients, and patients whose medical decisions are made by proxy will be excluded.
Trial population
Males and females who self-identify as Black with a pathologically confirmed diagnosis of prostate or breast cancer are eligible for this study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Standard of Care
Other interventionDrugs routinely administered for breast cancer per local standard.
Standard of Care
Other interventionDrugs routinely administered for prostate cancer per local standard.
Treatment groups
Trial outcomes
Primary outcomes
Immunohistochemistry
ER, PR, Her2 and AR status in breast and prostate tissues
Germline Mutations
Hereditary mutations in germline DND from breast and prostate
Mutational Landscape
tumor mutation burden in breast and prostate tissues
Sponsors and contacts
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Fox Chase Cancer Center
Lead sponsor
University of Miami Sylvester Comprehensive Cancer Center
Collaborator
Pfizer
Collaborator
The University of The West Indies
Collaborator
Kenya Medical Research Institute
Collaborator
University of Nairobi, Kenya
Collaborator
University of Abomey Calavi, Benin
Collaborator
Innovating Health International, Haiti
Collaborator
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborator
Ministry of Health and Social Services, Namibia
Collaborator
Morgan State University
Collaborator
University of Alabama, Tuscaloosa
Collaborator