African Cancer Genome: GMD

Breast Cancer Clinical Trial

Official title:

African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754658
• Other study ID #: 22-4004
• Status: Recruiting
• Start date: November 28, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2023
• Source: Fox Chase Cancer Center
• Contact: Camille Ragin, PhD, MPH
• Phone: 215-728-1148
• Email: Camille.Ragin[@]fccc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Standard of Care
Drugs routinely administered for breast cancer per local standard.
• Standard of Care
Drugs routinely administered for prostate cancer per local standard.

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (14)

Lead Sponsor

Collaborator

Fox Chase Cancer Center

Innovating Health International, Haiti, Institut de Recherche en Sciences de la Sante, Burkina Faso, Kenya Medical Research Institute, Ministry of Health and Social Services, Namibia, Morgan State University, Pfizer, The University of the West Indies at Cave Hill, Barbados, The University of The West Indies School of Clinical Medicine and Research, The Bahamas, The University of The West Indies, Mona, Jamaica, University of Abomey Calavi, Benin, University of Alabama, Tuscaloosa, University of Miami Sylvester Comprehensive Cancer Center, University of Nairobi, Kenya

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunohistochemistry	ER, PR, Her2 and AR status in breast and prostate tissues	Year 1-2
Primary	Germline Mutations	Hereditary mutations in germline DND from breast and prostate	Year 1-2
Primary	Mutational Landscape	tumor mutation burden in breast and prostate tissues	Year 2