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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: single arm for all patients

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clémence BASSE, MD; Phone Number: 01 56 24 55 39; Email: clemence.basse@curie.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Institut Mutualiste Montsouris
    • Contact: Alessio MARIOLO, MD
    • Principal Investigator: Alessio MARIOLO, MD
  • Paris, France
    • Recruiting
    • Institut Curie Paris
    • Principal Investigator: Nicolas Girard, MD
    • Contact: Nicolas Girard, MD; Email: nicolas.girard2@curie.fr
  • Suresnes, France
    • Recruiting
    • Hôpital Foch
    • Contact: Edouard SAGE, MD; Email: e.sage@hopital-foch.com
    • Principal Investigator: Edouard SAGE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Study Director: Clémence BASSE, MD, Institut Curie Paris

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 5, 2026

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: thymic epithelial tumors
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms
• Other Study ID Numbers: IC 2022-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No