NCT05558644

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2023-08-03
• Primary completion: 2026-10-05
• Completion: 2026-10-05
• First posted: 2022-09-28
• Last updated: 2025-09-08

Locations

3 sites across 1 country: France