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African Cancer Genome: GMD

Temple University Health System (TUHS) logo

Temple University Health System (TUHS)

Status

Enrolling

Conditions

Breast Cancer
Prostate Cancer

Treatments

Other: Standard of Care

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05754658
22-4004

Details and patient eligibility

About

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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,500 participants in 2 patient groups

Breast Cancer
Description:
Female patients
Treatment:
Other: Standard of Care
Other: Standard of Care
Prostate Cancer
Description:
Male patients
Treatment:
Other: Standard of Care
Other: Standard of Care

Trial contacts and locations

1

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Central trial contact

Sophia George, PhD; Camille Ragin, PhD, MPH

Data sourced from clinicaltrials.gov

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