Triple Negative Breast CancerNCT06646263
Cellular Immune Responses in Triple-negative Breast Cancer - High Throughput Immunogenetic Studies
An observational study of Triple Negative Breast Cancer, run by Institute of Applied Biosciences at 1 site in Greece.
Trial summary
This project introduces a novel methodology for the in-depth immunogenetic characterization of the TR gene repertoire in solid tumors, holding the promise to offer unprecedented insights into the TR anti-tumor specificity and the prognostic/predictive value of TR gene repertoire signatures. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2024to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study group includes patients diagnosed with TNBC. Each patient provided written informed consent, and paired samples of peripheral blood (PB) and tumor tissue were obtained at the time of diagnosis and before initiating any treatment. The selection of patients will be meticulously carried out by the PI and team members based on comprehensive clinical records, including clinicobiological characteristics. Further refinement of the study group will be contingent upon sample availability and the quality of biological material.
Who may be able to join
- Confirmed TNBC diagnosis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site
Institute of Applied Biosciences
Thessaloniki, Thessaloniki, 57001
About this study
This project introduces a novel methodology for the in-depth immunogenetic characterization of the TR gene repertoire in solid tumors, holding the promise to offer unprecedented insights into the TR anti-tumor specificity and the prognostic/predictive value of TR gene repertoire signatures.
Read the detailed description
The goal of this observational study is to address the role of T cells in the tumor microenvironment of TNBC.
In detail, this study aims to:
(i) explore the immunogenetic characteristics of the TR gene repertoire as informative prognostic/predictive biomarkers in TNBC (ii) identify immunogenic neoepitopes arising from common tumor-specific non-synonymous gene mutations, as well as the corresponding neoepitope-specific T cells (iii) describe, in single-cell resolution, the spatial organization of the intricate crosstalk between tumor cells and neoepitope specific-T cells, and (iv) delineate the functional properties of T cells within the TME.
All the experimental results, regarding the TR repertoire features and the spatial organization of the TME, will be correlated with clinical outcome measurements (e.g. overall survival, progression time), which are available from the detailed patients medical record.
- Conditions
- Triple Negative Breast Cancer
- Keywords
- T cells, Tumor-infiltrating lymphocytes, Next-generation sequencing, T cell receptor, Spatial transcriptomics, Neoepitopes, TR beta chain, TRb clonotypes, TRb gene repertoire, Cellular immunity
- Medical subject headings
- Triple Negative Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell receptor profiling as a potential biomarker in Triple-Negative Breast Cancer
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Mar 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
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.
- 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Applied Biosciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Cooperative Oncology Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646263
- Sponsor's protocol ID
- INAB017635
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Immune Responses in Triple-negative Breast Cancer - High Throughput Immunogenetic Studies
- ClinicalTrials.gov ID
- NCT06646263
- Acronym / sponsor ID
- INAB017635
- Conditions
- Triple Negative Breast Cancer
- Keywords
- T cells, Tumor-infiltrating lymphocytes, Next-generation sequencing, T cell receptor, Spatial transcriptomics, Neoepitopes, TR beta chain, TRb clonotypes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Applied BiosciencesUniversity, hospital or other
- Collaborators
- Hellenic Cooperative Oncology Group
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 17 Oct 2024 (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.
This project introduces a novel methodology for the in-depth immunogenetic characterization of the TR gene repertoire in solid tumors, holding the promise to offer unprecedented insights into the TR anti-tumor specificity and the prognostic/predictive value of TR gene repertoire signatures.
Detailed description
The goal of this observational study is to address the role of T cells in the tumor microenvironment of TNBC.
In detail, this study aims to:
(i) explore the immunogenetic characteristics of the TR gene repertoire as informative prognostic/predictive biomarkers in TNBC (ii) identify immunogenic neoepitopes arising from common tumor-specific non-synonymous gene mutations, as well as the corresponding neoepitope-specific T cells (iii) describe, in single-cell resolution, the spatial organization of the intricate crosstalk between tumor cells and neoepitope specific-T cells, and (iv) delineate the functional properties of T cells within the TME.
All the experimental results, regarding the TR repertoire features and the spatial organization of the TME, will be correlated with clinical outcome measurements (e.g. overall survival, progression time), which are available from the detailed patients medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study group includes patients diagnosed with TNBC. Each patient provided written informed consent, and paired samples of peripheral blood (PB) and tumor tissue were obtained at the time of diagnosis and before initiating any treatment. The selection of patients will be meticulously carried out by the PI and team members based on comprehensive clinical records, including clinicobiological characteristics. Further refinement of the study group will be contingent upon sample availability and the quality of biological material.
Key inclusion criteria (1 listed)
- Confirmed TNBC diagnosis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T cell receptor profiling as a potential biomarker in Triple-Negative Breast Cancer
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Institute of Applied Biosciences at 1 site in Greece.
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: enrolling by invitation, as of the sponsor's last update on 17 Oct 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
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?
T cell receptor profiling as a potential biomarker in Triple-Negative Breast Cancer (time frame: 4 years). 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 17 Oct 2024.