NCT05558644

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
5mo left

Started Aug 2023

Typical duration for not_applicable cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Aug 2023Oct 2026

First Submitted

Initial submission to the registry

September 20, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

August 3, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2026

Last Updated

September 8, 2025

Status Verified

February 1, 2025

Enrollment Period

3.2 years

First QC Date

September 20, 2022

Last Update Submit

September 2, 2025

Conditions

Cancer

Keywords

thymic epithelial tumors

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

single arm for all patients

EXPERIMENTAL

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

Interventions

single arm for all patientsOTHER

* 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.

single arm for all patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with suspicion of 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 centers.
  • Signed informed consent form of the patient.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut Curie Paris

Paris, France

RECRUITING

Institut Mutualiste Montsouris

Paris, France

RECRUITING

Hôpital FOCH

Suresnes, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Clémence BASSE, MD

    Institut Curie Paris

    STUDY DIRECTOR

Central Study Contacts

Clémence BASSE, MD

CONTACT

01 56 24 55 39clemence.basse@curie.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 28, 2022

Study Start

August 3, 2023

Primary Completion (Estimated)

October 5, 2026

Study Completion (Estimated)

October 5, 2026

Last Updated

September 8, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
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).

Locations

FR(3)