Triple Negative Breast CancerNCT05111067
Molecular Subtyping of Triple-negative Breast Cancer and African Ancestry-related Immunogenicity
An observational study of Triple Negative Breast Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- DNA and whole transcriptome mRNA sequencing
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2021to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Biological samples acquired from patient's with Triple-negative breast cancer
Who may be able to join
- Diagnosed with Triple-negative breast cancer
Who cannot join
- No diagnosis of Triple-negative breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study seeks to characterize the mRNA profile of TNBC in Nigeria and compare to a reference population in Nova Scotia. Insight into the unique tumor-immune profile of TNBC in Nigeria and the link between the West African-linked Duffy-antigen receptor for chemokines (DARC) and TNBC subtype will be explored for the first time.
Fresh frozen TNBC tissue from the African Research Group for Oncology (ARGO) and Dalhousie/NSHA breast cancer biobanks' will be processing and analyzed by the Genomics Core Facility at Dalhousie University. Clinical data is prospectively collected with specimen acquisition in the ARGO biobank. For the Dalhousie /NSHA biobank, clinical data will be retrospectively gathered from the medical record and migrated to an electronic database for prospective collection during the course of the study. Both cohorts of specimens will be run through DNA and whole transcriptome (mRNA) sequencing on the TSO500 platform (Illumina Ulc.). The tumor-immune microenvironment will be compared between cohorts and by mRNA cluster using the transcriptional signatures for 22 leukocyte populations and immune-regulating proteins CTLA-4 and PD-L1. Finally, tumor expression of DARC will be generated from the transcriptome data that will allow for an assessment of the relationship between DARC expression, TNBC mRNA clusters, and sociodemographic variables (i.e. race/ancestry, gender). Whole transcriptome data from The Cancer Genome Atlas will be pulled as the third cohort, including 55 TNBC specimens from African Americans.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- DNA and whole transcriptome mRNA sequencing
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA and whole transcriptome mRNA sequencingGenetic
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: DNA and whole transcriptome mRNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA and mRNA sequencing
Measured: 3 years
Duffy-antigen receptor for chemokines
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Obafemi Awolowo University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111067
- Sponsor's protocol ID
- 42127
- Status last verified
- Aug 2024
- First submitted
- 27 Oct 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Subtyping of Triple-negative Breast Cancer and African Ancestry-related Immunogenicity
- ClinicalTrials.gov ID
- NCT05111067
- Acronym / sponsor ID
- 42127
- Conditions
- Triple Negative Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Obafemi Awolowo University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study seeks to characterize the mRNA profile of TNBC in Nigeria and compare to a reference population in Nova Scotia. Insight into the unique tumor-immune profile of TNBC in Nigeria and the link between the West African-linked Duffy-antigen receptor for chemokines (DARC) and TNBC subtype will be explored for the first time.
Fresh frozen TNBC tissue from the African Research Group for Oncology (ARGO) and Dalhousie/NSHA breast cancer biobanks' will be processing and analyzed by the Genomics Core Facility at Dalhousie University. Clinical data is prospectively collected with specimen acquisition in the ARGO biobank. For the Dalhousie /NSHA biobank, clinical data will be retrospectively gathered from the medical record and migrated to an electronic database for prospective collection during the course of the study. Both cohorts of specimens will be run through DNA and whole transcriptome (mRNA) sequencing on the TSO500 platform (Illumina Ulc.). The tumor-immune microenvironment will be compared between cohorts and by mRNA cluster using the transcriptional signatures for 22 leukocyte populations and immune-regulating proteins CTLA-4 and PD-L1. Finally, tumor expression of DARC will be generated from the transcriptome data that will allow for an assessment of the relationship between DARC expression, TNBC mRNA clusters, and sociodemographic variables (i.e. race/ancestry, gender). Whole transcriptome data from The Cancer Genome Atlas will be pulled as the third cohort, including 55 TNBC specimens from African Americans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nova scotia TNBC cohort | – | Genetic: DNA and whole transcriptome mRNA sequencingDNA 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. |
| Nigerian TNBC cohort | – | Genetic: DNA and whole transcriptome mRNA sequencingDNA 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Biological samples acquired from patient's with Triple-negative breast cancer
Key inclusion criteria (1 listed)
- Diagnosed with Triple-negative breast cancer
Key exclusion criteria (1 listed)
- No diagnosis of Triple-negative breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA and whole transcriptome mRNA sequencingDNA 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). | Genetic | Nigerian TNBC cohort, Nova scotia TNBC cohort |
Primary outcome
DNA and mRNA sequencing
Time frame: 3 years
Duffy-antigen receptor for chemokines
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA and mRNA sequencing (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.