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

Cancer Clinical Trial

— IMMUNO-TET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558644
• Other study ID #: IC 2022-06 IMMUNO-TET
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: October 5, 2026

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: Clémence BASSE, MD
• Phone: 01 56 24 55 39
• Email: clemence.basse[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 5, 2026
• Est. primary completion date: October 5, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Institut Curie Paris	Paris
France	Institut Mutualiste Montsouris	Paris
France	Hôpital FOCH	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Characterisation of the immune environment of TETs	description of immune cells in the tumour environment, description of tumour infiltrating T cells	38 months
Primary	Establishment of a patient-derived xenograft mouse model.		38 months
Primary	somatic molecular characterisation of TETs	Molecular constitutional characterisation of TETs with the technique of theExome Sequencing (WES) on blood samples of patients with TETs	38 months
Secondary	Genomic characterisation of TETs	WES data analysis constitutional genetic alterations will be performed.	38 months
Secondary	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
Secondary	Identification of potential neoepitopes	Analysis of TETs single-cell RNA-seq data will be performed.	38 months
Secondary	Transcriptomic characterisation of TETs	Transcriptome sequencing analysis will be performed.	38 months
Secondary	Epigenetic characterisation of TETs	Epigenetic characterisation of TETs will be performed by molecular analyses.	38 months