Congenital Heart DefectsTHYMICNCT07019857
Impact of Thymectomy on Immunity in Infants After Cardiac Surgery
A study testing Blood sample collection at surgery time and 12 months later in people with Congenital Heart Defects and Thymectomy, run by Nantes University Hospital at 2 sites in France.
Trial summary
Heart surgery in infants typically involves complete removal of the thymus gland to improve access to the heart. However, the thymus plays a key role in developing the immune system in early childhood, especially in the production and maturation of T lymphocytes, which help the body defend itself against infections. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Congenital Heart Defects, Thymectomy, Immunological Deficiency Syndrome
- What is being tested?
- Blood sample collection at surgery time and 12 months later
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Jul 2025to 1 Dec 2027
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - Children aged between 0 and 6 months;
- Born at a gestational age > 37 weeks' gestation;
- With an indication for cardiac surgery under CEC at Nantes University Hospital;
- Cardiopediatric follow-up planned at Nantes University Hospital;
- Written agreement signed by legal guardians to participate in the study.
- For the control groups:
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- Control group A (cardiac surgery without thymectomy):
- Children aged between 0 and 6 months of age;
- Born at a gestational age > 37 SA;
- Indicated for thoracotomy cardiac surgery at Nantes University Hospital;
- Cardiopediatric follow-up planned at Nantes University Hospital;
- Written agreement signed by legal guardians to participate in the study.
- Control group B (non-cardiac surgery)
- Children aged between 0 and 6 months;
- Born at a gestational age > 37 SA;
- Indicated for non-cardiac surgery (ENT or visceral surgery at Nantes University Hospital);
- Planned follow-up surgery at Nantes University Hospital;
- Written agreement signed by legal guardians to participate in the study.
Who cannot join
- Gestational age < 37 SA;
- With a history of cardiac surgery under ECG;
- And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).
- And/or a history of partial or complete thymectomy;
- Receiving long-term immunosuppressive treatment;
- Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period;
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- parental refusal.
- - Gestational age < 37 SA;
- With a history of cardiac surgery under ECG;
- And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).
- And/or a history of partial or complete thymectomy;
- Receiving long-term immunosuppressive treatment;
- Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period;
- parental refusal.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Evelyne Gauvard contact
France2 sites, 2 recruiting
- Not yet recruiting
CHU de Nantes
Nantes, 44093
Alexis Chenouard, PH, 02 44 76 82 21, alexis.chenouard@chu-nantes.fr
Evelyne Gauvard, Evelyne.GAUVARD@chu-nantes.fr
- Recruiting
Chu de Nantes
Nantes, 44093
Alexis Chenouard, PH, 0244768221, alexis.chenouard@chu-nantes.fr
About this study
Official title: Impact of Thymectomy on Immune Response in Infants 12 Months After Cardiac Surgery: a Single-centre Prospective Study
Heart surgery in infants typically involves complete removal of the thymus gland to improve access to the heart. However, the thymus plays a key role in developing the immune system in early childhood, especially in the production and maturation of T lymphocytes, which help the body defend itself against infections.
The THYMIC study tests the hypothesis that partial removal of the thymus (partial thymectomy) during heart surgery may better preserve the child's immune function compared to total removal (complete thymectomy). The goal is to determine whether this conservative surgical approach could reduce the risk of immune system impairment and infections in the months following surgery.
Read more
This is a prospective, interventional, single-center study conducted at CHU de Nantes, involving 3 groups of infants:
- One group undergoing heart surgery with complete thymectomy;
- One group undergoing heart surgery with partial thymectomy;
- One control group undergoing heart or non-heart surgery without thymus removal. All infants enrolled will have two blood tests: one taken during their surgery and one taken one year later. These blood tests will quantify immune cells (T, B, NK cells), levels of antibodies, and vaccine responses. Parents will also be asked to fill out a questionnaire to record any infections their child experiences during the year after surgery.
By comparing the immune responses and infection rates among the groups, the researchers hope to better understand the long-term effects of thymectomy in infants. The results could support future recommendations to preserve part of the thymus when possible during heart surgery.
Participation in the study does not change the medical or surgical care of the child. The decision to perform a partial or complete thymectomy is made by the surgeon based on the child's anatomy. The additional blood samples are small in volume and follow current safety regulations.
Read the detailed description
The THYMIC study is a prospective, single-center, interventional clinical trial conducted at the University Hospital of Nantes (CHU de Nantes), France. It aims to evaluate the medium-term immunological impact of thymectomy (total versus partial) in infants undergoing cardiac surgery requiring cardiopulmonary bypass (CPB) before the age of 6 months.
Background and Rationale During most pediatric cardiac surgeries, the thymus is completely removed to allow better access to the heart and great vessels. However, the thymus plays a critical role in T-cell development during infancy, contributing to immune system maturation. Prior studies suggest that complete thymectomy in early life may result in persistent alterations in T-cell immunity and increased susceptibility to infections. Yet, the comparative impact of partial versus complete thymectomy on immune function remains poorly studied.
Partial thymectomy is technically feasible in selected cases depending on the anatomy, and could offer a balance between surgical access and immune preservation. The THYMIC study tests the hypothesis that partial thymectomy is associated with less impairment of cellular immunity at 12 months postoperatively and could therefore become the preferred surgical approach in appropriate cases.Study Design
This is a non-randomized, controlled study including 70 infants:
- 50 infants undergoing cardiac surgery with CPB and either partial or complete thymectomy (surgical decision made
The THYMIC study is a prospective, single-center, interventional clinical trial conducted at the University Hospital of Nantes (CHU de Nantes), France. It aims to evaluate the medium-term immunological impact of thymectomy (total versus partial) in infants undergoing cardiac surgery requiring cardiopulmonary bypass (CPB) before the age of 6 months.
Background and Rationale During most pediatric cardiac surgeries, the thymus is completely removed to allow better access to the heart and great vessels. However, the thymus plays a critical role in T-cell development during infancy, contributing to immune system maturation. Prior studies suggest that complete thymectomy in early life may result in persistent alterations in T-cell immunity and increased susceptibility to infections. Yet, the comparative impact of partial versus complete thymectomy on immune function remains poorly studied.
Partial thymectomy is technically feasible in selected cases depending on the anatomy, and could offer a balance between surgical access and immune preservation. The THYMIC study tests the hypothesis that partial thymectomy is associated with less impairment of cellular immunity at 12 months postoperatively and could therefore become the preferred surgical approach in appropriate cases.
Study Design
This is a non-randomized, controlled study including 70 infants:
- 50 infants undergoing cardiac surgery with CPB and either partial or complete thymectomy (surgical decision made intraoperatively),
- 10 infants undergoing cardiac surgery via thoracotomy without thymectomy (control group A),
- 10 infants undergoing non-cardiac surgery (e.g., digestive surgery) without thymectomy (control group B).
The study involves two blood draws:
- Baseline (preoperative): performed at anesthesia induction via central catheter (5 mL), including blood cell counts, lymphocyte immunophenotyping, immunoglobulin levels, and TRECs (if Guthrie test not already available).
- Follow-up (12 months postoperative): peripheral blood draw (5 mL), with repeated immunophenotyping, immunoglobulin levels, and post-vaccine serologies (e.g., diphtheria, tetanus, pneumococcus).
Parents are given a standardized infection monitoring questionnaire at hospital discharge, to be completed with their pediatrician or other care providers over the 12-month follow-up. A phone call is scheduled at 6 months to reinforce compliance. At 12 months, families return for the second blood draw and review of the infection questionnaire. An additional consultation is conducted 15 days later to provide results and arrange follow-up if needed.
Primary Objective To compare cellular immune profiles at 12 months between infants with partial versus complete thymectomy. Key markers include absolute counts of lymphocytes and subsets, and T-cell receptor excision circles (TRECs).
Secondary Objectives
To compare:
- Humoral immunity markers (B-cell subsets, immunoglobulin levels, vaccine responses),
- Clinical outcomes such as the number, type, and severity of infections (e.g., hospitalization, ICU admission, antibiotic use) between groups.
Methodology Notes Due to the impossibility of preoperative randomization (surgical decision on thymectomy extent depends on intraoperative anatomy), this is a non-randomized study with group allocation based on surgical findings.
All data are pseudonymized and collected in an electronic case report form (eCRF). Immunological assays are processed via the CHU's certified laboratories (CIMNA platform and hematology department).
Ethical Considerations and Risk-Benefit Assessment The study poses minimal risk. Blood samples are within safe volume limits for infants, and pain is minimized using anesthetic cream and inhaled analgesia (EMLA, MEOPA). Thymectomy extent is based solely on clinical indication and does not depend on study participation. Families benefit from enhanced immunological monitoring, which could identify and help manage acquired immune deficiencies.
Significance This study may provide critical data to support a shift toward more conservative surgical practices regarding thymus preservation in early cardiac surgery, with the potential to reduce long-term immunological sequelae in this vulnerable population.
- Being tested
- Blood sample collection at surgery time and 12 months later
- Keywords
- Thymectomy, Cardiac Surgery, Infant, Immunity, Lymphocytes, TRECs, Vaccination, Infection
- Medical subject headings
- Heart Defects, Congenital, Immunologic Deficiency Syndromes, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collection at surgery time and 12 months laterDiagnostic test
each participant undergoes a blood test 1) at surgery time and 2) 12 months after surgery. These 5mL samples include:
- Blood cell count
- TREC dosage
- Complete Lymphocytes immunophenotyping
- Immunoglobulin dosage
| Study group | Role | What they receive |
|---|---|---|
| Complete Thymectomy Group | Experimental | Infants undergoing cardiac surgery with cardiopulmonary bypass (CPB), during which a complete thymectomy is performed for surgical access to the heart and great vessels. The extent of thymus resection is determined by the cardiac surgeon intraoperatively, based on anatomical considerations Receives: Diagnostic Test: Blood sample collection at surgery time and 12 months later |
| Partial Thymectomy Group | Experimental | Infants undergoing cardiac surgery with CPB, during which a partial thymectomy is performed, with an effort to preserve thymic tissue when anatomically feasible. Receives: Diagnostic Test: Blood sample collection at surgery time and 12 months later |
| Control Group (No Thymectomy | Active comparator | Infants undergoing:
* Cardiac surgery by thoracotomy without thymectomy (e.g., for aortic coarctation) or
* Non-cardiac surgery (e.g., digestive procedures) with complete preservation of the thymus.
These patients serve as immunological reference controls Receives: Diagnostic Test: Blood sample collection at surgery time and 12 months later |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-Lymphocyte response
biological endpoint with absolute quantification of LyTs, LyT subpopulations and TRECs.
Measured: 12 months after surgery
Secondary outcomes (2)
Humoral response
absolute quantification of LyB, weighted immunoglobulin assays and post-vaccination serologies
Measured: 12 months after surgery
Clinical impact
the number of infectious episodes, their severity as assessed by the need for hospitalisation, the number of days spent in intensive care, the number of days on antibiotics, etc.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start25 Jul 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- three groups according to type of surgery (complete thymectomy, partial thymectomy, control)
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Chenouard, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019857
- Sponsor's protocol ID
- RC24_0411
- Acronym
- THYMIC
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2025
- Last updated
- 16 Apr 2026
- 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Thymectomy on Immune Response in Infants 12 Months After Cardiac Surgery: a Single-centre Prospective Study
- ClinicalTrials.gov ID
- NCT07019857
- Acronym / sponsor ID
- THYMIC / RC24_0411
- Keywords
- Thymectomy, Cardiac Surgery, Infant, Immunity, Lymphocytes, TRECs, Vaccination, Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 13 Jun 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.
Heart surgery in infants typically involves complete removal of the thymus gland to improve access to the heart. However, the thymus plays a key role in developing the immune system in early childhood, especially in the production and maturation of T lymphocytes, which help the body defend itself against infections.
The THYMIC study tests the hypothesis that partial removal of the thymus (partial thymectomy) during heart surgery may better preserve the child's immune function compared to total removal (complete thymectomy). The goal is to determine whether this conservative surgical approach could reduce the risk of immune system impairment and infections in the months following surgery.
This is a prospective, interventional, single-center study conducted at CHU de Nantes, involving 3 groups of infants:
- One group undergoing heart surgery with complete thymectomy;
- One group undergoing heart surgery with partial thymectomy;
- One control group undergoing heart or non-heart surgery without thymus removal. All infants enrolled will have two blood tests: one taken during their surgery and one taken one year later. These blood tests will quantify immune cells (T, B, NK cells), levels of antibodies, and vaccine responses. Parents will also be asked to fill out a questionnaire to record any infections their child experiences during the year after surgery.
By comparing the immune responses and infection rates among the groups, the researchers hope to better understand the long-term effects of thymectomy in infants. The results could support future recommendations to preserve part of the thymus when possible during heart surgery.
Participation in the study does not change the medical or surgical care of the child. The decision to perform a partial or complete thymectomy is made by the surgeon based on the child's anatomy. The additional blood samples are small in volume and follow current safety regulations.
Detailed description
The THYMIC study is a prospective, single-center, interventional clinical trial conducted at the University Hospital of Nantes (CHU de Nantes), France. It aims to evaluate the medium-term immunological impact of thymectomy (total versus partial) in infants undergoing cardiac surgery requiring cardiopulmonary bypass (CPB) before the age of 6 months.
Background and Rationale During most pediatric cardiac surgeries, the thymus is completely removed to allow better access to the heart and great vessels. However, the thymus plays a critical role in T-cell development during infancy, contributing to immune system maturation. Prior studies suggest that complete thymectomy in early life may result in persistent alterations in T-cell immunity and increased susceptibility to infections. Yet, the comparative impact of partial versus complete thymectomy on immune function remains poorly studied.
Partial thymectomy is technically feasible in selected cases depending on the anatomy, and could offer a balance between surgical access and immune preservation. The THYMIC study tests the hypothesis that partial thymectomy is associated with less impairment of cellular immunity at 12 months postoperatively and could therefore become the preferred surgical approach in appropriate cases.Study Design
This is a non-randomized, controlled study including 70 infants:
- 50 infants undergoing cardiac surgery with CPB and either partial or complete thymectomy (surgical decision made
The THYMIC study is a prospective, single-center, interventional clinical trial conducted at the University Hospital of Nantes (CHU de Nantes), France. It aims to evaluate the medium-term immunological impact of thymectomy (total versus partial) in infants undergoing cardiac surgery requiring cardiopulmonary bypass (CPB) before the age of 6 months.
Background and Rationale During most pediatric cardiac surgeries, the thymus is completely removed to allow better access to the heart and great vessels. However, the thymus plays a critical role in T-cell development during infancy, contributing to immune system maturation. Prior studies suggest that complete thymectomy in early life may result in persistent alterations in T-cell immunity and increased susceptibility to infections. Yet, the comparative impact of partial versus complete thymectomy on immune function remains poorly studied.
Partial thymectomy is technically feasible in selected cases depending on the anatomy, and could offer a balance between surgical access and immune preservation. The THYMIC study tests the hypothesis that partial thymectomy is associated with less impairment of cellular immunity at 12 months postoperatively and could therefore become the preferred surgical approach in appropriate cases.
Study Design
This is a non-randomized, controlled study including 70 infants:
- 50 infants undergoing cardiac surgery with CPB and either partial or complete thymectomy (surgical decision made intraoperatively),
- 10 infants undergoing cardiac surgery via thoracotomy without thymectomy (control group A),
- 10 infants undergoing non-cardiac surgery (e.g., digestive surgery) without thymectomy (control group B).
The study involves two blood draws:
- Baseline (preoperative): performed at anesthesia induction via central catheter (5 mL), including blood cell counts, lymphocyte immunophenotyping, immunoglobulin levels, and TRECs (if Guthrie test not already available).
- Follow-up (12 months postoperative): peripheral blood draw (5 mL), with repeated immunophenotyping, immunoglobulin levels, and post-vaccine serologies (e.g., diphtheria, tetanus, pneumococcus).
Parents are given a standardized infection monitoring questionnaire at hospital discharge, to be completed with their pediatrician or other care providers over the 12-month follow-up. A phone call is scheduled at 6 months to reinforce compliance. At 12 months, families return for the second blood draw and review of the infection questionnaire. An additional consultation is conducted 15 days later to provide results and arrange follow-up if needed.
Primary Objective To compare cellular immune profiles at 12 months between infants with partial versus complete thymectomy. Key markers include absolute counts of lymphocytes and subsets, and T-cell receptor excision circles (TRECs).
Secondary Objectives
To compare:
- Humoral immunity markers (B-cell subsets, immunoglobulin levels, vaccine responses),
- Clinical outcomes such as the number, type, and severity of infections (e.g., hospitalization, ICU admission, antibiotic use) between groups.
Methodology Notes Due to the impossibility of preoperative randomization (surgical decision on thymectomy extent depends on intraoperative anatomy), this is a non-randomized study with group allocation based on surgical findings.
All data are pseudonymized and collected in an electronic case report form (eCRF). Immunological assays are processed via the CHU's certified laboratories (CIMNA platform and hematology department).
Ethical Considerations and Risk-Benefit Assessment The study poses minimal risk. Blood samples are within safe volume limits for infants, and pain is minimized using anesthetic cream and inhaled analgesia (EMLA, MEOPA). Thymectomy extent is based solely on clinical indication and does not depend on study participation. Families benefit from enhanced immunological monitoring, which could identify and help manage acquired immune deficiencies.
Significance This study may provide critical data to support a shift toward more conservative surgical practices regarding thymus preservation in early cardiac surgery, with the potential to reduce long-term immunological sequelae in this vulnerable population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- three groups according to type of surgery (complete thymectomy, partial thymectomy, control)
| Arm | Type | Receives |
|---|---|---|
| Complete Thymectomy Group | Experimental | Diagnostic Test: Blood sample collection at surgery time and 12 months laterInfants undergoing cardiac surgery with cardiopulmonary bypass (CPB), during which a complete thymectomy is performed for surgical access to the heart and great vessels. The extent of thymus resection is determined by the cardiac surgeon intraoperatively, based on anatomical considerations |
| Partial Thymectomy Group | Experimental | Diagnostic Test: Blood sample collection at surgery time and 12 months laterInfants undergoing cardiac surgery with CPB, during which a partial thymectomy is performed, with an effort to preserve thymic tissue when anatomically feasible. |
| Control Group (No Thymectomy | Active comparator | Diagnostic Test: Blood sample collection at surgery time and 12 months laterInfants undergoing: * Cardiac surgery by thoracotomy without thymectomy (e.g., for aortic coarctation) or * Non-cardiac surgery (e.g., digestive procedures) with complete preservation of the thymus. These patients serve as immunological reference controls |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- - Children aged between 0 and 6 months;
- Born at a gestational age > 37 weeks' gestation;
- With an indication for cardiac surgery under CEC at Nantes University Hospital;
- Cardiopediatric follow-up planned at Nantes University Hospital;
- Written agreement signed by legal guardians to participate in the study.
Key exclusion criteria (14 listed)
- Gestational age < 37 SA;
- With a history of cardiac surgery under ECG;
- And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).
- And/or a history of partial or complete thymectomy;
- Receiving long-term immunosuppressive treatment;
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 |
|---|---|---|
| Blood sample collection at surgery time and 12 months latereach participant undergoes a blood test 1) at surgery time and 2) 12 months after surgery. These 5mL samples include: * Blood cell count * TREC dosage * Complete Lymphocytes immunophenotyping * Immunoglobulin dosage | Diagnostic test | Complete Thymectomy Group, Control Group (No Thymectomy, Partial Thymectomy Group |
Primary outcome
T-Lymphocyte response
Time frame: 12 months after surgery
biological endpoint with absolute quantification of LyTs, LyT subpopulations and TRECs.
2 secondary outcomes
Humoral response
Time frame: 12 months after surgery
Clinical impact
Time frame: 12 months after surgery
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 16 Apr 2026.
- 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.
Evelyne Gauvard contact
Alexis Chenouard, PH principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection at surgery time and 12 months later in people with Congenital Heart Defects and Thymectomy, run by Nantes University Hospital at 2 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 18 inclusion and 14 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Alexis Chenouard, PH (02 44 76 82 21, alexis.chenouard@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-Lymphocyte response (time frame: 12 months after surgery). 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 16 Apr 2026.