NCT06646263

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 prognostic/predictive value of TR gene repertoire signatures.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
23mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Mar 2024Apr 2028

Study Start

First participant enrolled

March 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

3.1 years

First QC Date

October 15, 2024

Last Update Submit

October 15, 2024

Conditions

Triple Negative Breast Cancer

Keywords

T cellsTumor-infiltrating lymphocytesNext-generation sequencingT cell receptorSpatial transcriptomicsNeoepitopesTR beta chainTRb clonotypesTRb gene repertoireCellular immunity

Outcome Measures

Primary Outcomes (1)

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

    4 years

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- Confirmed TNBC diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Applied Biosciences

Thessaloniki, Thessaloniki, 57001, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens include FFPE tumor samples and peripheral blood (PB) samples derived from TNBC patients.

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 17, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

October 17, 2024

Record last verified: 2024-10

Locations

GR(1)