Molecular Subtyping of Triple-negative Breast Cancer and African Ancestry-related Immunogenicity

NCT05111067 | Completed

• 1 other identifier: 42127
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Triple-negative breast cancer (TNBC) is a heterogeneous disease that is associated with a younger age of onset, worse stage matched-outcomes, and women of African ancestry in North America. A higher incidence of TNBC is also seen in West Africa, despite unique environmental, socioeconomic and modifiable risk factors. Transcriptome analysis of TNBC has delineated four distinct subgroups with therapeutic and prognostic significance. With further characterization, important regional differences have emerged between populations of African vs. European ancestry. These differences may have significant implications for the efficacy of novel TNBC-targeted therapy and need to be further evaluated. Transcriptional data on TNBC in sub-Saharan African also offers the opportunity to evaluate the relationship between breast cancer phenotype and ancestry-linked differences in the tumor-immune microenvironment.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• DNA and mRNA sequencing

  3 years

• Duffy-antigen receptor for chemokines

  3 years

Study Arms (2)

Nova scotia TNBC cohort

DNA and whole transcriptome mRNA sequencing, including total mutational burden and microsatellite instability, will be performed using the TruSight Oncology 500 (TSO500) platform (Illumina Canada, Ulc). Transcriptome data will be used to categorize specimens into one of four distinct mRNA subgroups and will be compared between cohorts.

Genetic: DNA and whole transcriptome mRNA sequencing

Nigerian TNBC cohort

DNA and whole transcriptome mRNA sequencing, including total mutational burden and microsatellite instability, will be performed using the TruSight Oncology 500 (TSO500) platform (Illumina Canada, Ulc). Transcriptome data will be used to categorize specimens into one of four distinct mRNA subgroups and will be compared between cohorts.

Genetic: DNA and whole transcriptome mRNA sequencing

Interventions

DNA and whole transcriptome mRNA sequencing GENETIC

DNA and whole transcriptome mRNA sequencing, including total mutational burden and microsatellite instability, will be performed using the TruSight Oncology 500 (TSO500) platform (Illumina Canada, Ulc).

Nigerian TNBC cohort; Nova scotia TNBC cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Biological samples acquired from patient's with Triple-negative breast cancer

You may qualify if:

• Diagnosed with Triple-negative breast cancer

You may not qualify if:

• No diagnosis of Triple-negative breast cancer

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Obafemi Awolowo University: collaborator

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia, B2Y 1A7, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fresh frozen Triple-negative breast cancer tissue.

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

DNA

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)