Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: single arm for all patients.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
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.
Interventions
- 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.
Primary outcome measures
- Somatic molecular characterisation of TETs [Time frame: 38 months]
- Characterisation of the immune environment of TETs [Time frame: 38 months]
- Molecular characterisation of TETs [Time frame: 38 months]
Secondary outcome measures (5)
- Genomic characterisation of TETs [Time frame: 38 months]
- Characterisation of potential alterations in signalling pathways to identify potential therapeutic targets [Time frame: 38 months]
- Identification of potential neoepitopes [Time frame: 38 months]
- Transcriptomic characterisation of TETs [Time frame: 38 months]
- Epigenetic characterisation of TETs [Time frame: 38 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 3 centers
- Institut Curie Paris — Paris
- Institut Mutualiste Montsouris — Paris
- Hôpital FOCH — Suresnes
Identifiers
NCT: NCT05558644 · IC 2022-06