Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Other: single arm for all patients

• Registration Number: NCT05558644
• Lead Sponsor: Institut Curie

Brief Summary

The IMMUNO-TET trial aims to assess the feasibility of characterising the immune environment of TETs and the constitutional and somatic molecular profiles of patients with localised thymic epithelial tumour (TET).

Detailed Description

In this prospective study, patients undergoing thymectomy and thymomectomy as part of routine care undergo the following care pathway:

1. During the pre-surgical visit (for n = 50 patients): as part of routine care, a blood sample is collected for analysis of CBC, leukocytes, lymphocytes, CRP, ferritinemia, TSH, T3L, T4L, anti-acetycholine receptor antibodies, ...CMV, EBV, HSV, HIV serologies, ...and HLA class I and class II typing.

2. During thymectomy and thymomectomy surgery, the following samples are taken (for n = 50 patients):

* 6 blood samples on EDTA tubes are collected at the time of surgery for analyses.

* 3 fresh samples of the surgical specimen are taken by the pathologist: tumour T, juxta-tumour J and distant D locations for analyses by flow cytometry and RNA sequencing. Anatomopathology blocks/slides are also cut in the same way (tumour T, juxta-tumour J and distant D locations) for additional exploratory analyses.

* The feasibility of developing patient-derived xenografts (PDX) from TETs will be tested for n = 20 tumor samples. These models will allow to test potential therapeutic agents for this pathology.

3. During the 1st month (+/- 7 days) post-surgery check-up, a blood sample is taken again (for n = 50 patients) for routine care: CBC, leukocytes, lymphocytes, CRP, ferritinemia, anti-acetycholine receptor antibodies and for peripheral immune system analysis at a distance from surgery and for constitutional molecular analysis.

Informed consent is given to participate in this prospective study.

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-28
• Study Start: 2023-08-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Primary Completion: 2026-10-05
• Study Completion: 2026-10-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patient with suspicion of localised thymic epithelial tumour.
2. Age ≥ 18 years.
3. Treatment-naïve patient for this disease.
4. Patient with an indication for thymectomy and thymomectomy in one of the partner centers.
5. Signed informed consent form of the patient.

Exclusion Criteria

1. Neoadjuvant chemotherapy.
2. No social security affiliation.
3. Person under legal protection.
4. Other neoplasia in progress or cured within the last 3 years (except for operated carcinoma in situ).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm for all patients	single arm for all patients	single arm for all patients tumor samples will be taken for RNA sequencing of epithelial tumour cells during surgery. blood samples will be taken for Exome Sequencing (WES) at baseline, during surgery and one month post surgery.

Primary Outcome Measures

Name	Time	Method
Somatic molecular characterisation of TETs	38 months	Description of genetic abnormalities in thymic tumours compared to non-tumourous thymic tissue (Whole Exome Sequencing RNA-sequencing technique, DNA Optical mapping);
Characterisation of the immune environment of TETs	38 months	Description of immune cells in the tumour environment, description of tumour infiltrating T cells
Establishment of a patient-derived xenograft mouse model.	38 months	Patient-derived xenograft mouse model established from thymic tumour.
Molecular characterisation of TETs	38 months	Molecular constitutional characterisation of TETs with the technique of the Exome Sequencing (WES) on blood samples of patients with TETs

Secondary Outcome Measures

Name	Time	Method
Transcriptomic characterisation of TETs	38 months	Transcriptome sequencing analysis will be performed.
Characterisation of potential alterations in signalling pathways to identify potential therapeutic targets	38 months	Molecular analyses will be performed to identify potential alterations in signalling pathways that can be targeted by new therapies.
Identification of potential neoepitopes	38 months	Analysis of TETs single-cell RNA-seq data will be performed.
Epigenetic characterisation of TETs	38 months	Epigenetic characterisation of TETs will be performed by molecular analyses.
Genomic characterisation of TETs	38 months	WES data analysis constitutional genetic alterations will be performed.

Trial Locations

Locations (3)

Institut Curie Paris; 🇫🇷 Paris, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Hôpital FOCH; 🇫🇷 Suresnes, France