Clinical trial NCT05754658: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Prostate Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Miami Sylvester Comprehensive Cancer Center
name: Pfizer
name: The University of The West Indies, Mona, Jamaica
name: Kenya Medical Research Institute
name: University of Nairobi, Kenya
name: University of Abomey Calavi, Benin
name: Innovating Health International, Haiti
name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: The University of the West Indies at Cave Hill, Barbados
name: The University of The West Indies School of Clinical Medicine and Research, The Bahamas
name: Ministry of Health and Social Services, Namibia
name: Morgan State University
name: University of Alabama, Tuscaloosa
First posted: 2023-03-06
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Immunohistochemistry
timeFrame: Year 1-2
measure: Germline Mutations
timeFrame: Year 1-2
measure: Mutational Landscape
timeFrame: Year 2
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References: