ImmunotherapyT-ECHNICONCT07155811
Lymphocyte Function Testing in Immuno-oncology
A study testing test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO in people with Immunotherapy and Advanced Solid Tumor Malignancies, run by Centre Leon Berard.
Trial summary
Several studies have shown that the presence and levels of IFN-γ may correlate with better responses to immunotherapy. Higher baseline levels of IFN-γ and an increase in its production during treatment have been associated with better clinical outcomes in patients receiving immunotherapy such as anti-PD-1/PD-L1 or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunotherapy, Advanced Solid Tumor Malignancies
- What is being tested?
- test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2025to 23 Sep 2025
- 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
- Male or female aged 18 years or older with a confirmed diagnosis of solid tumors (any type of tumor) in advanced or metastatic stages
- Patients who are due to start standard treatment with anti-PD1, anti-PDL1, or anti-CTLA4 (combinations of ICIs are permitted) at the Léon Bérard Center:
- Cohort A: ICI without concomitant chemotherapy
- Cohort B: ICI with concomitant chemotherapy
- Patients who have understood, dated, and signed the consent form for this study before undergoing any protocol-specific procedures.
- Patients affiliated with or covered by a social security system.
Who cannot join
- Patients to be treated with immunotherapy in combination with targeted therapy.
- Patients treated with chemotherapy within the last 21 days prior to D1 of immunotherapy
- Pregnant or breastfeeding patients.
- Patients with other known cancers that are progressing or requiring the initiation of another treatment.
- Patients with psychological, family, geographical, or social circumstances that, in the investigator's judgment, could potentially prevent the signing of an informed consent form and/or compliance with study procedures.
- Patients in one or more of the following situations: subject to legal protection measures, deprived of liberty by judicial or administrative decision, receiving psychiatric care, admitted to a health or social care facility for purposes other than research
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Single-center, Clinico-biological Cohort Evaluating the Automated VIDAS STIMM T Test in Patients With Advanced/Metastatic Solid Tumors Treated With Standard Immunotherapy
Several studies have shown that the presence and levels of IFN-γ may correlate with better responses to immunotherapy. Higher baseline levels of IFN-γ and an increase in its production during treatment have been associated with better clinical outcomes in patients receiving immunotherapy such as anti-PD-1/PD-L1 or anti-CTLA4.
To date, there is no simple, rapid, automated, and standardized test to assess T-cell functionality and quantify the level of immunosuppression in individual patients. To address this medical need, bioMérieux has developed the VIDAS® STIMM™ T RUO automated functional immune test, which can determine a patient's immune status by measuring IFN-γ production by T lymphocytes after stimulation by a mitogen in approximately four hours without human intervention. The aim of this study is to evaluate whether the amount of IFN-γ produced by T lymphocytes, as measured by an automated VIDAS® STIMM™ T functional immune test, correlates with disease progression in patients with advanced/metastatic solid tumors treated with standard immunotherapy.
- Conditions
- Immunotherapy, Advanced Solid Tumor Malignancies
- Being tested
- test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUODiagnostic test
The functional assessment of T lymphocytes is based on the use of the VIDAS® STIMM™ T RUO test, which will be performed on freshly collected whole blood in lithium heparin tubes without gel separators. Blood samples will be sent to the Immunology Laboratory at E. Herriot Hospital (Prof. Guillaume Monneret). T lymphocytes will be stimulated ex vivo for 3.5 hours (non-antigen-dependent stimulation by PHA) on the VIDAS®3 automated system (bioMérieux).
The automated system then performs a assay (immunofluorescence technique) to quantify the concentrations of IFN-γ in the supernatant of each sample. The entire process is automated, and results are obtained within 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Cohorte A: Immunothérapie sans chimiothérapie concomitante | Active comparator | Immunotherapy without concurrent chemotherapy Receives: Diagnostic Test: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO |
| Cohorte B : Immunothérapie avec chimiothérapie concomitante | Active comparator | Immunotherapy with concurrent chemotherapy Receives: Diagnostic Test: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main objective of the study
Evaluate whether there is a correlation between T-cell function and radiological response under standard immunotherapy
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start23 Sep 2025 (estimated)
- Primary completion23 Sep 2025 (estimated)
- Study completion23 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155811
- Sponsor's protocol ID
- ET24-155 T-ECHNICO
- Other IDs
- EU number
- Acronym
- T-ECHNICO
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-center, Clinico-biological Cohort Evaluating the Automated VIDAS STIMM T Test in Patients With Advanced/Metastatic Solid Tumors Treated With Standard Immunotherapy
- ClinicalTrials.gov ID
- NCT07155811
- Acronym / sponsor ID
- T-ECHNICO / ET24-155 T-ECHNICO
- Conditions
- Immunotherapy, Advanced Solid Tumor Malignancies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 23 Sep 2025 (estimated)
- Primary completion
- 23 Sep 2025 (estimated)
- Study completion
- 23 Sep 2025 (estimated)
- First posted
- 4 Sep 2025 (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.
Several studies have shown that the presence and levels of IFN-γ may correlate with better responses to immunotherapy. Higher baseline levels of IFN-γ and an increase in its production during treatment have been associated with better clinical outcomes in patients receiving immunotherapy such as anti-PD-1/PD-L1 or anti-CTLA4.
To date, there is no simple, rapid, automated, and standardized test to assess T-cell functionality and quantify the level of immunosuppression in individual patients. To address this medical need, bioMérieux has developed the VIDAS® STIMM™ T RUO automated functional immune test, which can determine a patient's immune status by measuring IFN-γ production by T lymphocytes after stimulation by a mitogen in approximately four hours without human intervention. The aim of this study is to evaluate whether the amount of IFN-γ produced by T lymphocytes, as measured by an automated VIDAS® STIMM™ T functional immune test, correlates with disease progression in patients with advanced/metastatic solid tumors treated with standard immunotherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohorte A: Immunothérapie sans chimiothérapie concomitante | Active comparator | Diagnostic Test: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUOImmunotherapy without concurrent chemotherapy |
| Cohorte B : Immunothérapie avec chimiothérapie concomitante | Active comparator | Diagnostic Test: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUOImmunotherapy with concurrent chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged 18 years or older with a confirmed diagnosis of solid tumors (any type of tumor) in advanced or metastatic stages
- Patients who are due to start standard treatment with anti-PD1, anti-PDL1, or anti-CTLA4 (combinations of ICIs are permitted) at the Léon Bérard Center:
- Patients who have understood, dated, and signed the consent form for this study before undergoing any protocol-specific procedures.
- Patients affiliated with or covered by a social security system.
Key exclusion criteria (6 listed)
- Patients to be treated with immunotherapy in combination with targeted therapy.
- Patients treated with chemotherapy within the last 21 days prior to D1 of immunotherapy
- Pregnant or breastfeeding patients.
- Patients with other known cancers that are progressing or requiring the initiation of another treatment.
- Patients with psychological, family, geographical, or social circumstances that, in the investigator's judgment, could potentially prevent the signing of an informed consent form and/or compliance with study procedures.
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 |
|---|---|---|
| test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUOThe functional assessment of T lymphocytes is based on the use of the VIDAS® STIMM™ T RUO test, which will be performed on freshly collected whole blood in lithium heparin tubes without gel separators. Blood samples will be sent to the Immunology Laboratory at E. Herriot Hospital (Prof. Guillaume Monneret). T lymphocytes will be stimulated ex vivo for 3.5 hours (non-antigen-dependent stimulation by PHA) on the VIDAS®3 automated system (bioMérieux). The automated system then performs a assay (immunofluorescence technique) to quantify the concentrations of IFN-γ in the supernatant of each sample. The entire process is automated, and results are obtained within 4 hours. | Diagnostic test | Cohorte A: Immunothérapie sans chimiothérapie concomitante, Cohorte B : Immunothérapie avec chimiothérapie concomitante |
Primary outcome
Main objective of the study
Time frame: up to 12 months
Evaluate whether there is a correlation between T-cell function and radiological response under standard immunotherapy
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 4 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO in people with Immunotherapy and Advanced Solid Tumor Malignancies, run by Centre Leon Berard.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Armelle VINCENEUX, Dr (04 26 55 68 33, armelle.vinceneux@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main objective of the study (time frame: up to 12 months). 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 4 Sep 2025.