African Cancer Genome: GMD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorFox Chase Cancer Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard of Care

    Other intervention

    Drugs routinely administered for breast cancer per local standard.

  • Standard of Care

    Other intervention

    Drugs routinely administered for prostate cancer per local standard.

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: Breast Cancer1 intervention
Group B: Prostate Cancer1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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