Cellular Immune Responses in Triple-negative Breast Cancer - High Throughput Immunogenetic Studies

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Triple Negative Breast Cancer

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 57001
    • Institute of Applied Biosciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

- Confirmed TNBC diagnosis

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
T cell receptor profiling as a potential biomarker in Triple-Negative Breast Cancer	4 years

Collaborators and Investigators

• Sponsor: Institute of Applied Biosciences
• Collaborators: Hellenic Cooperative Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Tumor-infiltrating lymphocytes; T cells; Next-generation sequencing; Cellular immunity; Spatial transcriptomics; T cell receptor; Neoepitopes; TR beta chain; TRb clonotypes; TRb gene repertoire
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: INAB017635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No