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

NCT06646263 — Enrolling by invitation, 150 participants, Institute of Applied Biosciences

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RegistryNCT06646263
StatusEnrolling by invitation
Study typeObservational
Enrollment150 (Estimated)
SponsorInstitute of Applied Biosciences (Other); collaborators: Hellenic Cooperative Oncology Group
ConditionsTriple Negative Breast Cancer
Datesstart 2024-03-01, primary completion 2027-04-01 (estimated), completion 2028-04-01 (estimated), first posted 2024-10-17, last updated 2024-10-17
Locations1 site in Greece

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-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.

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+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.

+Outcome measures

Primary outcomes

  • T cell receptor profiling as a potential biomarker in Triple-Negative Breast Cancer [4 years]

+Eligibility

Sex: Female

Inclusion Criteria:

\- Confirmed TNBC diagnosis

Exclusion Criteria:

\-

+Locations (1)

FacilityCityCountryStatus
Institute of Applied BiosciencesThessaloniki, ThessalonikiGreece