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

NCT ID: NCT06646263

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2028-04-30

Brief Summary

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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

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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

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Triple Negative Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\- Confirmed TNBC diagnosis

Exclusion Criteria

\-
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hellenic Cooperative Oncology Group

OTHER

Sponsor Role collaborator

Institute of Applied Biosciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Applied Biosciences

Thessaloniki, Thessaloniki, Greece

Site Status

Countries

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Greece

Other Identifiers

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INAB017635

Identifier Type: -

Identifier Source: org_study_id

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