NCT05754658 · Fox Chase Cancer Center
African Cancer Genome: GMD
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Standard of Care
Drugs routinely administered for breast cancer per local standard.
OTHER
Standard of Care
Drugs routinely administered for prostate cancer per local standard.
Primary outcome measures
Immunohistochemistry
Time frame: Year 1-2
ER, PR, Her2 and AR status in breast and prostate tissues
Germline Mutations
Time frame: Year 1-2
Hereditary mutations in germline DND from breast and prostate
Mutational Landscape
Time frame: Year 2
tumor mutation burden in breast and prostate tissues
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Philadelphia, Pennsylvania
Collaborators
University of Miami Sylvester Comprehensive Cancer Center, Pfizer, The University of The West Indies, Kenya Medical Research Institute, University of Nairobi, Kenya, University of Abomey Calavi, Benin, Innovating Health International, Haiti, Institut de Recherche en Sciences de la Sante, Burkina Faso, Ministry of Health and Social Services, Namibia, Morgan State University, University of Alabama, Tuscaloosa
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2025 · Source of record for eligibility and locations