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African Cancer Genome: GMD

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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

Tracking Information
First Submitted Date February 13, 2023
First Posted Date March 6, 2023
Last Update Posted Date March 27, 2023
Actual Study Start Date November 28, 2022
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2023)
  • 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
Original Primary Outcome Measures
 (submitted: February 22, 2023)
  • Receptor Status [ 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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title African Cancer Genome: GMD
Official Title African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
Blood and FFPE samples for DNA and RNA extraction
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.
Condition
  • Breast Cancer
  • Prostate Cancer
Intervention
  • 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.
Study Groups/Cohorts
  • Breast Cancer
    Female patients
    Intervention: Other: Standard of Care
  • Prostate Cancer
    Male patients
    Intervention: Other: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 22, 2023)		 1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2024
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Camille Ragin, PhD, MPH 215-728-1148 Camille.Ragin@fccc.edu
Contact: Sophia George, PhD sophia.george@med.miami.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05754658
Other Study ID Numbers 22-4004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Camille Ragin, PhD, MPH, Fox Chase Cancer Center
Original Responsible Party Same as current
Current Study Sponsor Fox Chase Cancer Center
Original Study Sponsor Same as current
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
Investigators Not Provided
PRS Account Fox Chase Cancer Center
Verification Date March 2023