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Trial Title:
African Cancer Genome: GMD
NCT ID:
NCT05754658
Condition:
Breast Cancer
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Standard of Care
Description:
Drugs routinely administered for breast cancer per local standard.
Arm group label:
Breast Cancer
Intervention type:
Other
Intervention name:
Standard of Care
Description:
Drugs routinely administered for prostate cancer per local standard.
Arm group label:
Prostate Cancer
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.
Criteria for eligibility:
Study pop:
Males and females who self-identify as Black with a pathologically confirmed diagnosis of
prostate or breast cancer are eligible for this study.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
CAMILLE RAGIN, PhD, MPH
Phone:
215-728-1148
Email:
camille.ragin@fccc.edu
Contact backup:
Last name:
SOPHIA GEORGE, PhD
Email:
Sophia.george@med.miami.edu
Start date:
November 28, 2022
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Fox Chase Cancer Center
Agency class:
Other
Collaborator:
Agency:
University of Miami Sylvester Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
The University of The West Indies, Mona, Jamaica
Agency class:
Other
Collaborator:
Agency:
Kenya Medical Research Institute
Agency class:
Other
Collaborator:
Agency:
University of Nairobi, Kenya
Agency class:
Other
Collaborator:
Agency:
University of Abomey Calavi, Benin
Agency class:
Other
Collaborator:
Agency:
Innovating Health International, Haiti
Agency class:
Other
Collaborator:
Agency:
Institut de Recherche en Sciences de la Sante, Burkina Faso
Agency class:
Other
Collaborator:
Agency:
The University of the West Indies at Cave Hill, Barbados
Agency class:
Other
Collaborator:
Agency:
The University of The West Indies School of Clinical Medicine and Research, The Bahamas
Agency class:
Other
Collaborator:
Agency:
Ministry of Health and Social Services, Namibia
Agency class:
Other
Collaborator:
Agency:
Morgan State University
Agency class:
Other
Collaborator:
Agency:
University of Alabama, Tuscaloosa
Agency class:
Other
Source:
Fox Chase Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754658
