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NCT Number: NCT05558644

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie Paris, Paris, France

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About this study

In this prospective study, patients undergoing thymectomy and thymomectomy as part of routine care undergo the following care pathway:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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).

Treatment and study plan

single arm for all patients

Other
  • 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.

Primary outcomes

  1. Somatic molecular characterisation of TETs

    Time frame: 38 months

    Description of genetic abnormalities in thymic tumours compared to non-tumourous thymic tissue (Whole Exome Sequencing RNA-sequencing technique, DNA Optical mapping);

  2. Characterisation of the immune environment of TETs

    Time frame: 38 months

    Description of immune cells in the tumour environment, description of tumour infiltrating T cells

  3. Molecular characterisation of TETs

    Time frame: 38 months

    Molecular constitutional characterisation of TETs with the technique of the Exome Sequencing (WES) on blood samples of patients with TETs

Secondary outcomes

  1. Genomic characterisation of TETs

    Time frame: 38 months

    WES data analysis constitutional genetic alterations will be performed.

  2. Characterisation of potential alterations in signalling pathways to identify potential therapeutic targets

    Time frame: 38 months

    Molecular analyses will be performed to identify potential alterations in signalling pathways that can be targeted by new therapies.

  3. Identification of potential neoepitopes

    Time frame: 38 months

    Analysis of TETs single-cell RNA-seq data will be performed.

  4. Transcriptomic characterisation of TETs

    Time frame: 38 months

    Transcriptome sequencing analysis will be performed.

  5. Epigenetic characterisation of TETs

    Time frame: 38 months

    Epigenetic characterisation of TETs will be performed by molecular analyses.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas GIRARD, MD

CONTACT

[email protected]

0156245539

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: IMMUNO-TET

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Sep 28, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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