African Cancer Genome: GMD

Sponsor

Fox Chase Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05754658

Collaborator

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

1,500

Enrollment

Location

19.1

Anticipated Duration (Months)

78.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Prostate Cancer	Other: Standard of Care Other: Standard of Care

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 28, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Breast Cancer Female patients	Other: Standard of Care Drugs routinely administered for breast cancer per local standard.
Prostate Cancer Male patients	Other: Standard of Care Drugs routinely administered for prostate cancer per local standard.

Arm

Intervention/Treatment

Breast Cancer

Female patients

Other: Standard of Care

Drugs routinely administered for breast cancer per local standard.

Prostate Cancer

Male patients

Other: Standard of Care

Drugs routinely administered for prostate cancer per local standard.

Outcome Measures

Primary Outcome Measures

Receptor Status [Year 1-2]
ER, PR, Her2 and AR status in breast and prostate tissues
Germline Mutations [Year 1-2]
Hereditary mutations in germline DND from breast and prostate
Mutational Landscape [Year 2]
tumor mutation burden in breast and prostate tissues

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111

Sponsors and Collaborators

Fox Chase Cancer Center
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

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Camille Ragin, PhD, MPH, Professor, Fox Chase Cancer Center

ClinicalTrials.gov Identifier:

NCT05754658

Other Study ID Numbers:

22-4004

First Posted:

Mar 6, 2023

Last Update Posted:

Mar 6, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Mar 6, 2023