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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).
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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single arm for all patients | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Genomic characterisation of TETs | WES data analysis constitutional genetic alterations will be performed. | 38 months |
| Characterisation of potential alterations in signalling pathways to identify potential therapeutic targets |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas GIRARD, MD | Contact | 0156245539 | nicolas.girard2@curie.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas GIRARD, MD | Institut Curie Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie Paris | Recruiting | Paris | France |
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
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).
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Molecular analyses will be performed to identify potential alterations in signalling pathways that can be targeted by new therapies.
| 38 months |
| Identification of potential neoepitopes | Analysis of TETs single-cell RNA-seq data will be performed. | 38 months |
| Transcriptomic characterisation of TETs | Transcriptome sequencing analysis will be performed. | 38 months |
| Epigenetic characterisation of TETs | Epigenetic characterisation of TETs will be performed by molecular analyses. | 38 months |
| Institut Mutualiste Montsouris | Recruiting | Paris | France |
|
| Hôpital FOCH | Recruiting | Suresnes | France |
|