CancerIMMUNO-TETNCT05558644
Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)
A study testing single arm for all patients in people with Cancer, run by Institut Curie at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- single arm for all patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Aug 2023to 2 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Institut Curie Paris
Paris
Nicolas Girard, MD, nicolas.girard2@curie.fr
Nicolas Girard, MD
- Recruiting
Institut Mutualiste Montsouris
Paris
Alessio MARIOLO, MD
Alessio MARIOLO, MD
- Recruiting
Hôpital FOCH
Suresnes
Edouard SAGE, MD, e.sage@hopital-foch.com
Edouard SAGE, MD
About this study
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).
Read the 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.
- Conditions
- Cancer
- Being tested
- single arm for all patients
- Keywords
- thymic epithelial tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single arm for all patientsOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: single arm for all patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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);
Measured: 38 months
Characterisation of the immune environment of TETs
Description of immune cells in the tumour environment, description of tumour infiltrating T cells
Measured: 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
Measured: 38 months
Secondary outcomes (5)
Genomic characterisation of TETs
WES data analysis constitutional genetic alterations will be performed.
Measured: 38 months
Characterisation of potential alterations in signalling pathways to identify potential therapeutic targets
Molecular analyses will be performed to identify potential alterations in signalling pathways that can be targeted by new therapies.
Measured: 38 months
Identification of potential neoepitopes
Analysis of TETs single-cell RNA-seq data will be performed.
Measured: 38 months
Transcriptomic characterisation of TETs
Transcriptome sequencing analysis will be performed.
Measured: 38 months
Epigenetic characterisation of TETs
Epigenetic characterisation of TETs will be performed by molecular analyses.
Measured: 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start3 Aug 2023
- Primary completion2 Oct 2028 (estimated)
- Study completion2 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas GIRARD, MD, Study director, Institut Curie Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558644
- Sponsor's protocol ID
- IC 2022-06
- Acronym
- IMMUNO-TET
- Status last verified
- Jul 2026
- First submitted
- 20 Sep 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)
- ClinicalTrials.gov ID
- NCT05558644
- Acronym / sponsor ID
- IMMUNO-TET / IC 2022-06
- Conditions
- Cancer
- Keywords
- thymic epithelial tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 2 Oct 2028 (estimated)
- Study completion
- 2 Oct 2029 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm for all patients | Experimental | Other: single arm for all patientssingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Somatic molecular characterisation of TETs
Time frame: 38 months
Description of genetic abnormalities in thymic tumours compared to non-tumourous thymic tissue (Whole Exome Sequencing RNA-sequencing technique, DNA Optical mapping);
Characterisation of the immune environment of TETs
Time frame: 38 months
Description of immune cells in the tumour environment, description of tumour infiltrating T cells
Molecular characterisation of TETs
Time frame: 38 months
Molecular constitutional characterisation of TETs with the technique of the Exome Sequencing (WES) on blood samples of patients with TETs
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas GIRARD, MD study director
Institut Curie Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single arm for all patients in people with Cancer, run by Institut Curie at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas GIRARD, MD (0156245539, nicolas.girard2@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatic molecular characterisation of TETs (time frame: 38 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.