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Trial Title:
Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)
NCT ID:
NCT05558644
Condition:
Cancer
Conditions: Keywords:
thymic epithelial tumors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
single arm for all patients
Description:
- 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.
Arm group label:
single arm for all patients
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Curie Paris
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Clémence Basse, MD
Email:
clemence.basse@curie.fr
Investigator:
Last name:
Clémence Basse, MD
Email:
Principal Investigator
Facility:
Name:
Institut Mutualiste Montsouris
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Alessio MARIOLO, MD
Investigator:
Last name:
Alessio MARIOLO, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital FOCH
Address:
City:
Suresnes
Country:
France
Status:
Recruiting
Contact:
Last name:
Edouard SAGE, MD
Email:
e.sage@hopital-foch.com
Investigator:
Last name:
Edouard SAGE, MD
Email:
Principal Investigator
Start date:
August 3, 2023
Completion date:
October 5, 2026
Lead sponsor:
Agency:
Institut Curie
Agency class:
Other
Source:
Institut Curie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05558644
