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OpenTrials
Enrolling by Invitation

NCT Number: NCT06646263

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.

Enrolling by Invitation

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Institute of Applied Biosciences

Thessaloniki, 57001, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed TNBC diagnosis

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. T cell receptor profiling as a potential biomarker in Triple-Negative Breast Cancer

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Institute of Applied Biosciences

Other

Collaborators

  • Hellenic Cooperative Oncology Group

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 17, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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