Breast CancerNCT05754658
African Cancer Genome: GMD
An observational study of Breast Cancer and Prostate Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- How many people
- 854 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2022to 10 Jul 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females who self-identify as Black with a pathologically confirmed diagnosis of prostate or breast cancer are eligible for this study.
Who may be able to join
- 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.
Who cannot join
- Patients age <18 year, incarcerated patients, and patients whose medical decisions are made by proxy will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers
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.
- Conditions
- Breast Cancer, Prostate Cancer
- Being tested
- Standard of Care
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Drugs routinely administered for breast cancer per local standard.
Standard of CareOther
Drugs routinely administered for prostate cancer per local standard.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Female patients Receives: Other: Standard of Care | |
| Prostate Cancer | Male patients Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistochemistry
ER, PR, Her2 and AR status in breast and prostate tissues
Measured: Year 1-2
Germline Mutations
Hereditary mutations in germline DND from breast and prostate
Measured: Year 1-2
Mutational Landscape
tumor mutation burden in breast and prostate tissues
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start28 Nov 2022
- Primary completion10 Jul 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 854 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Camille Ragin, PhD, MPH, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754658
- Sponsor's protocol ID
- 22-4004
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers
- ClinicalTrials.gov ID
- NCT05754658
- Acronym / sponsor ID
- 22-4004
- Conditions
- Breast Cancer, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 854 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- 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
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Other: Standard of CareFemale patients |
| Prostate Cancer | – | Other: Standard of CareMale patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females who self-identify as Black with a pathologically confirmed diagnosis of prostate or breast cancer are eligible for this study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients age <18 year, incarcerated patients, and patients whose medical decisions are made by proxy will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareDrugs routinely administered for breast cancer per local standard. | Other | Breast Cancer |
| Standard of CareDrugs routinely administered for prostate cancer per local standard. | Other | Prostate Cancer |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemistry (time frame: Year 1-2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.