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NCT05558644 | Recruiting | Cancer


Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)
Sponsor:

Curie Institute

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).

Condition or disease

Cancer

Intervention/treatment

single arm for all patients

Phase

Not Applicable

Detailed Description:

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.}}

Study Type : Interventional
Estimated Enrollment : 50 participants
Masking : None (Open Label)
Primary Purpose : Other
Official Title : Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)
Actual Study Start Date : August 3, 2023
Estimated Primary Completion Date : October 5, 2026
Estimated Study Completion Date : October 5, 2026
Arm Intervention/treatment

Experimental: single arm for all patients

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

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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).

Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)

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Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

France,

Curie Institute Paris

Paris, France,

Recruiting

France,

Montsouris Mutualist Institute

Paris, France,

Recruiting

France,

FOCH Hospital

Suresnes, France,

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