African Cancer Genome: GMD

Recruiting

• Conditions: Prostate Cancer; Breast Cancer
• Interventions: Other: Standard of Care

• Registration Number: NCT05754658
• Lead Sponsor: Fox Chase Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-28
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer	Standard of Care	Female patients
Prostate Cancer	Standard of Care	Male patients

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States