TRIGGER-2: Immunologic Risk of Pregnancy in Women With Lung Transplantion : a National Multicentric Study

Sponsor

Nantes University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05689905

Collaborator

Institut de Recherche en Santé Respiratoire (Other)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Transplantation Graft Rejection Pregnancy	Diagnostic Test: HLA typing of the children

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Immunologic Risk of Pregnancy in Women With Lung Transplant

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Common HLA antigens with the lung donor Children who have common HLA antigens with the lung donor of their mother	Diagnostic Test: HLA typing of the children The HLA typing is made on a mouth swab of the children, that is a painless non-invasive procedure.
No common HLA antigens with the lung donor Children without common HLA antigens with the lung donor of their mother.	Diagnostic Test: HLA typing of the children The HLA typing is made on a mouth swab of the children, that is a painless non-invasive procedure.

Arm

Intervention/Treatment

Common HLA antigens with the lung donor

Children who have common HLA antigens with the lung donor of their mother

Diagnostic Test: HLA typing of the children

The HLA typing is made on a mouth swab of the children, that is a painless non-invasive procedure.

No common HLA antigens with the lung donor

Children without common HLA antigens with the lung donor of their mother.

Diagnostic Test: HLA typing of the children

The HLA typing is made on a mouth swab of the children, that is a painless non-invasive procedure.

Outcome Measures

Primary Outcome Measures

Risk of humoral rejection if common HLA antigen between child and graft. [Baseline]
Identification of common HLA antigen between child and graft by HLA typing

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Refusal of consent by the patient and/or one of the two parents

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nantes University Hospital
Institut de Recherche en Santé Respiratoire

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT05689905

Other Study ID Numbers:

RC22_0581

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 19, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nantes University Hospital

Lung Transplantations

Pregnancy

Transplant Rejection

Transplantation Immunology

Study Results

No Results Posted as of Jan 19, 2023