Clinical trial NCT05558644: Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)
Official title: Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: thymic epithelial tumors
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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.

Eligibility criteria: Inclusion Criteria:

1. Patient with suspicion of localised thymic epithelial tumour.
2. Age ≥ 18 years.
3. Treatment-naïve patient for this disease.
4. Patient with an indication for thymectomy and thymomectomy in one of the partner centers.
5. Signed informed consent form of the patient.

Exclusion Criteria:

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

Primary outcomes:
measure: Somatic molecular characterisation of TETs
timeFrame: 38 months
measure: Characterisation of the immune environment of TETs
timeFrame: 38 months
measure: Establishment of a patient-derived xenograft mouse model.
timeFrame: 38 months
measure: Molecular characterisation of TETs
timeFrame: 38 months
Secondary outcomes:
measure: Genomic characterisation of TETs
timeFrame: 38 months
measure: Characterisation of potential alterations in signalling pathways to identify potential therapeutic targets
timeFrame: 38 months
measure: Identification of potential neoepitopes
timeFrame: 38 months
measure: Transcriptomic characterisation of TETs
timeFrame: 38 months
measure: Epigenetic characterisation of TETs
timeFrame: 38 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie Paris
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Suresnes
country: France
facility: Hôpital FOCH
Study officials:
affiliation: Institut Curie Paris
name: Clémence BASSE, MD
role: STUDY_DIRECTOR
References: