Viewing Study NCT06646263



Ignite Creation Date: 2024-10-26 @ 3:43 PM
Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06646263
Status: ENROLLING_BY_INVITATION
Last Update Posted: None
First Post: 2024-10-15

Brief Title: Cellular Immune Responses in Triple-negative Breast Cancer - High Throughput Immunogenetic Studies
Sponsor: None
Organization: None

Study Overview

Official Title: Cellular Immune Responses in Triple-negative Breast Cancer - High Throughput Immunogenetic Studies
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 prognosticpredictive 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 prognosticpredictive 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 eg overall survival progression time which are available from the detailed patients medical record

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None