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African Cancer Genome: GMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05754658
Recruitment Status : Recruiting
First Posted : March 6, 2023
Last Update Posted : March 27, 2023
Sponsor:
Collaborators:
University of Miami Sylvester Comprehensive Cancer Center
Pfizer
The University of The West Indies, Mona, Jamaica
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
The University of the West Indies at Cave Hill, Barbados
The University of The West Indies School of Clinical Medicine and Research, The Bahamas
Ministry of Health and Social Services, Namibia
Morgan State University
University of Alabama, Tuscaloosa
Information provided by (Responsible Party):
Camille Ragin, PhD, MPH, Fox Chase Cancer Center

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Breast Cancer Prostate Cancer Other: Standard of Care

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers
Actual Study Start Date : November 28, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Breast Cancer
Female patients
 Other: Standard of Care
Drugs routinely administered for breast cancer per local standard.
Prostate Cancer
Male patients
 Other: Standard of Care
Drugs routinely administered for prostate cancer per local standard.


Outcome Measures
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Primary Outcome Measures :
  1. Immunohistochemistry [ Time Frame: Year 1-2 ]
    ER, PR, Her2 and AR status in breast and prostate tissues

  2. Germline Mutations [ Time Frame: Year 1-2 ]
    Hereditary mutations in germline DND from breast and prostate

  3. Mutational Landscape [ Time Frame: Year 2 ]
    tumor mutation burden in breast and prostate tissues


Biospecimen Retention:   Samples With DNA
Blood and FFPE samples for DNA and RNA extraction

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05754658


Contacts
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Contact: Camille Ragin, PhD, MPH 215-728-1148 Camille.Ragin@fccc.edu
Contact: Sophia George, PhD sophia.george@med.miami.edu

Locations
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United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: CAMILLE RAGIN, PhD, MPH    215-728-1148    camille.ragin@fccc.edu   
Contact: SOPHIA GEORGE, PhD       Sophia.george@med.miami.edu   
Sponsors and Collaborators
Fox Chase Cancer Center
University of Miami Sylvester Comprehensive Cancer Center
Pfizer
The University of The West Indies, Mona, Jamaica
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
The University of the West Indies at Cave Hill, Barbados
The University of The West Indies School of Clinical Medicine and Research, The Bahamas
Ministry of Health and Social Services, Namibia
Morgan State University
University of Alabama, Tuscaloosa
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Camille Ragin, PhD, MPH, Professor, Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT05754658    
Other Study ID Numbers: 22-4004
First Posted: March 6, 2023    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases