Lung TransplantationTRIGGER-2NCT05689905
Immunologic Risk of Pregnancy in Women With Lung Transplantion : a National Multicentric Study
An observational study of Lung Transplantation and Graft Rejection, run by Nantes University Hospital at 9 sites in France.
Trial summary
TRIGGER 1 is a previous study that evaluate the immunological risk of pregnancy in women with lung transplants in France, whose pregnancy has ended between January 1, 2012 and December 31, 2021. The primary endpoint is the occurrence of humoral rejection with a year after pregnancy. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Transplantation, Graft Rejection, Pregnancy
- What is being tested?
- HLA typing of the children
- How many people
- 11 participants
- Where
- 9 sitesFrance
- Study dates
- 27 Feb 2024to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cohort of female lung transplant patients, a rare pathology, and their children.
Who may be able to join
- Children born between 01/01/2012 and 31/12/2021 of female patients over 18 years old with lung transplantation (mono, uni or cardio pulmonary) in France,
- Alive at the time of our study.
- Legal guardians' consent for oral swabbing of their child and HLA typing on this swab
- Affiliated or beneficiaries of a social security system or similar
Who cannot join
- Refusal of consent by the patient and/or one of the two parents
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Bordeaux University Hospital
Bordeaux, 33000
Grenoble University Hospital
Grenoble, 38700
Marie Lannelongue Hospital (GHSJ)
Le Plessis-Robinson, 92350
Civils Hospitals Lyon
Lyon, 69002
AP-HM
Marseille, 13005
Nantes University Hospital
Nantes, Loire Atlantique, 44093
Cochin Hospital (AP-HP)
Paris, 75014
Strasbourg University Hospital
Strasbourg, 67200
Foch Hospital
Suresnes, 92150
About this study
Official title: Immunologic Risk of Pregnancy in Women With Lung Transplant
TRIGGER 1 is a previous study that evaluate the immunological risk of pregnancy in women with lung transplants in France, whose pregnancy has ended between January 1, 2012 and December 31, 2021. The primary endpoint is the occurrence of humoral rejection with a year after pregnancy.
TRIGGER 2 aims to evaluate the risk of humoral rejection if there are common antigens between the child and the lung donor. We will collect HLA typing from children to compare them to the HLA typing of the mother, the lung donor and the antibodies produced if there are.
Read more
Thus, it will help us to suggest recommendations to limit the immunological risk of pregnancy for lung transplant women.
Lung transplantation is the treatment of choice of terminal chronic respiratory failure, such as cystic fibrosis and pulmonary hypertension. Young female patient of childbearing age are concerned.
For many years, given the risk of maternal and fetal complications, pregnancies were not recommended. Studies on large cohorts of transplanted patients, particularly kidney transplanted patients, have made it possible to study the risks of maternal, obstetrical and neonatal complications.
A few studies have been published in lung transplantation on small numbers of patients. However, these publications reporting on the fate of pregnancies in cohorts of lung transplant patients do not mentioned the immunological risk, with in particular the absence of studies on the risk of humoral rejection, appearance of anti-HLA (Human Leukocyte Antigens) antibodies (Ac) and the possible appearance of anti-HLA Ac directed against the donor (donor specific antibody, DSA).
TRIGGER 1 is a previous study, whose main objective is to evaluate the immunological risk of pregnancy in women with lung transplants (mono-, bi-, or cardiopulmonary) in France, whose pregnancy has ended between January 1, 2012 and December 31, 2021. The primary endpoint is the occurrence of humoral rejection within 1 year after pregnancy.
For this study TRIGGER2, we will collect the HLA typing of the children for pregnancies that resulted in the birth of a child. Thus, we will be able to compare the HLA typing of the children with the HLA typings of the mother and the lung donor, and the antibodies produced by the mother. The primary endpoint is to evaluate the risk of humoral rejection if there are common HLA antigens between the child and the lung donor.
- Conditions
- Lung Transplantation, Graft Rejection, Pregnancy
- Being tested
- HLA typing of the children
- Keywords
- Lung Transplantations, Pregnancy, Transplant Rejection, Transplantation Immunology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA typing of the childrenDiagnostic test
The HLA typing is made on a mouth swab of the children, that is a painless non-invasive procedure.
| Study group | Role | What they receive |
|---|---|---|
| Common HLA antigens with the lung donor | Children who have common HLA antigens with the lung donor of their mother Receives: Diagnostic Test: HLA typing of the children | |
| No common HLA antigens with the lung donor | Children without common HLA antigens with the lung donor of their mother. Receives: Diagnostic Test: HLA typing of the children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of humoral rejection if common HLA antigen between child and graft.
Identification of common HLA antigen between child and graft by HLA typing
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start27 Feb 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Santé Respiratoire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689905
- Sponsor's protocol ID
- RC22_0581
- Acronym
- TRIGGER-2
- Status last verified
- May 2025
- First submitted
- 30 Nov 2022
- Last updated
- 17 Mar 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Risk of Pregnancy in Women With Lung Transplant
- ClinicalTrials.gov ID
- NCT05689905
- Acronym / sponsor ID
- TRIGGER-2 / RC22_0581
- Conditions
- Lung Transplantation, Graft Rejection, Pregnancy
- Keywords
- Lung Transplantations, Pregnancy, Transplant Rejection, Transplantation Immunology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Institut de Recherche en Santé Respiratoire
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 19 Jan 2023 (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.
TRIGGER 1 is a previous study that evaluate the immunological risk of pregnancy in women with lung transplants in France, whose pregnancy has ended between January 1, 2012 and December 31, 2021. The primary endpoint is the occurrence of humoral rejection with a year after pregnancy.
TRIGGER 2 aims to evaluate the risk of humoral rejection if there are common antigens between the child and the lung donor. We will collect HLA typing from children to compare them to the HLA typing of the mother, the lung donor and the antibodies produced if there are.
Thus, it will help us to suggest recommendations to limit the immunological risk of pregnancy for lung transplant women.
Lung transplantation is the treatment of choice of terminal chronic respiratory failure, such as cystic fibrosis and pulmonary hypertension. Young female patient of childbearing age are concerned.
For many years, given the risk of maternal and fetal complications, pregnancies were not recommended. Studies on large cohorts of transplanted patients, particularly kidney transplanted patients, have made it possible to study the risks of maternal, obstetrical and neonatal complications.
A few studies have been published in lung transplantation on small numbers of patients. However, these publications reporting on the fate of pregnancies in cohorts of lung transplant patients do not mentioned the immunological risk, with in particular the absence of studies on the risk of humoral rejection, appearance of anti-HLA (Human Leukocyte Antigens) antibodies (Ac) and the possible appearance of anti-HLA Ac directed against the donor (donor specific antibody, DSA).
TRIGGER 1 is a previous study, whose main objective is to evaluate the immunological risk of pregnancy in women with lung transplants (mono-, bi-, or cardiopulmonary) in France, whose pregnancy has ended between January 1, 2012 and December 31, 2021. The primary endpoint is the occurrence of humoral rejection within 1 year after pregnancy.
For this study TRIGGER2, we will collect the HLA typing of the children for pregnancies that resulted in the birth of a child. Thus, we will be able to compare the HLA typing of the children with the HLA typings of the mother and the lung donor, and the antibodies produced by the mother. The primary endpoint is to evaluate the risk of humoral rejection if there are common HLA antigens between the child and the lung donor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common HLA antigens with the lung donor | – | Diagnostic Test: HLA typing of the childrenChildren who have common HLA antigens with the lung donor of their mother |
| No common HLA antigens with the lung donor | – | Diagnostic Test: HLA typing of the childrenChildren without common HLA antigens with the lung donor of their mother. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort of female lung transplant patients, a rare pathology, and their children.
Key inclusion criteria (4 listed)
- Children born between 01/01/2012 and 31/12/2021 of female patients over 18 years old with lung transplantation (mono, uni or cardio pulmonary) in France,
- Alive at the time of our study.
- Legal guardians' consent for oral swabbing of their child and HLA typing on this swab
- Affiliated or beneficiaries of a social security system or similar
Key exclusion criteria (1 listed)
- Refusal of consent by the patient and/or one of the two parents
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 |
|---|---|---|
| HLA typing of the childrenThe HLA typing is made on a mouth swab of the children, that is a painless non-invasive procedure. | Diagnostic test | Common HLA antigens with the lung donor, No common HLA antigens with the lung donor |
Primary outcome
Risk of humoral rejection if common HLA antigen between child and graft.
Time frame: Baseline
Identification of common HLA antigen between child and graft by HLA typing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation and Graft Rejection, run by Nantes University Hospital at 9 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of humoral rejection if common HLA antigen between child and graft. (time frame: Baseline). 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 17 Mar 2026.