African Cancer Genome: GMD

NCT ID: NCT05754658

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-28

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Breast Cancer Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast Cancer

Female patients

Standard of Care

Intervention Type OTHER

Drugs routinely administered for breast cancer per local standard.

Prostate Cancer

Male patients

Standard of Care

Intervention Type OTHER

Drugs routinely administered for prostate cancer per local standard.

Interventions

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Standard of Care

Drugs routinely administered for breast cancer per local standard.

Intervention Type OTHER

Standard of Care

Drugs routinely administered for prostate cancer per local standard.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami Sylvester Comprehensive Cancer Center

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

The University of The West Indies, Mona, Jamaica

UNKNOWN

Sponsor Role collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

University of Nairobi, Kenya

UNKNOWN

Sponsor Role collaborator

University of Abomey Calavi, Benin

UNKNOWN

Sponsor Role collaborator

Innovating Health International, Haiti

UNKNOWN

Sponsor Role collaborator

Institut de Recherche en Sciences de la Sante, Burkina Faso

OTHER_GOV

Sponsor Role collaborator

The University of the West Indies at Cave Hill, Barbados

UNKNOWN

Sponsor Role collaborator

The University of The West Indies School of Clinical Medicine and Research, The Bahamas

UNKNOWN

Sponsor Role collaborator

Ministry of Health and Social Services, Namibia

OTHER_GOV

Sponsor Role collaborator

Morgan State University

OTHER

Sponsor Role collaborator

University of Alabama, Tuscaloosa

OTHER

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Camille Ragin, PhD, MPH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Camille Ragin, PhD, MPH

Role: CONTACT

215-728-1148

Sophia George, PhD

Role: CONTACT

Facility Contacts

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CAMILLE RAGIN, PhD, MPH

Role: primary

215-728-1148

SOPHIA GEORGE, PhD

Role: backup

Other Identifiers

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22-4004

Identifier Type: -

Identifier Source: org_study_id

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