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

Sponsor

Institut Curie (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05558644

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: single arm for all patients	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Feb 15, 2026

Anticipated Study Completion Date :

Feb 15, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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]
somatic molecular characterisation of TETs [38 months]
Molecular constitutional characterisation of TETs with the technique of theExome Sequencing (WES) on blood samples of patients with TETs

Secondary Outcome Measures

Genomic characterisation of TETs [38 months]
Characterisation of potential alterations in signalling pathways to identify potential therapeutic targets [38 months]
Identification of potential neoepitopes [38 months]
Transcriptomic characterisation of TETs [38 months]
Epigenetic characterisation of TETs [38 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with localised thymic epithelial tumour.
Age ≥ 18 years.
Treatment-naïve patient for this disease.
Patient with an indication for thymectomy and thymomectomy in one of the partner centres.
Signed informed consent of the patient.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Institut Curie

Investigators

Principal Investigator: Clémence BASSE, MD, Institut Curie Paris
Principal Investigator: Agathe SEGUIN, MD, Institut Mutualiste Montsouris
Principal Investigator: Edouard SAGE, Hôpital FOCH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Curie

ClinicalTrials.gov Identifier:

NCT05558644

Other Study ID Numbers:

IC 2022-06

First Posted:

Sep 28, 2022

Last Update Posted:

Sep 28, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut Curie

thymic epithelial tumors

Additional relevant MeSH terms:

Neoplasms, Glandular and Epithelial

Study Results

No Results Posted as of Sep 28, 2022