Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05689905
Status:
RECRUITING
Last Update Posted:
2024-07-25
First Post:
2022-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunologic Risk of Pregnancy in Women With Lung Transplantion : a National Multicentric Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Saliva swab from the mother's child with a lung transplant."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of humoral rejection if common HLA antigen between child and graft.', 'timeFrame': 'Baseline', 'description': 'Identification of common HLA antigen between child and graft by HLA typing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Transplantations', 'Pregnancy', 'Transplant Rejection', 'Transplantation Immunology'], 'conditions': ['Lung Transplantation', 'Graft Rejection', 'Pregnancy']}, 'descriptionModule': {'briefSummary': '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.\n\nTRIGGER 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.\n\nThus, it will help us to suggest recommendations to limit the immunological risk of pregnancy for lung transplant women.\n\nLung 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.\n\nFor 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.\n\nA 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).\n\nTRIGGER 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.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort of female lung transplant patients, a rare pathology, and their children.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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,\n* Alive at the time of our study.\n* Legal guardians' consent for oral swabbing of their child and HLA typing on this swab\n* Affiliated or beneficiaries of a social security system or similar\n\nExclusion Criteria:\n\n\\- Refusal of consent by the patient and/or one of the two parents"}, 'identificationModule': {'nctId': 'NCT05689905', 'acronym': 'TRIGGER-2', 'briefTitle': 'Immunologic Risk of Pregnancy in Women With Lung Transplantion : a National Multicentric Study', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Immunologic Risk of Pregnancy in Women With Lung Transplant', 'orgStudyIdInfo': {'id': 'RC22_0581'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Common HLA antigens with the lung donor', 'description': 'Children who have common HLA antigens with the lung donor of their mother', 'interventionNames': ['Diagnostic Test: HLA typing of the children']}, {'label': 'No common HLA antigens with the lung donor', 'description': 'Children without common HLA antigens with the lung donor of their mother.', 'interventionNames': ['Diagnostic Test: HLA typing of the children']}], 'interventions': [{'name': 'HLA typing of the children', 'type': 'DIAGNOSTIC_TEST', 'description': 'The HLA typing is made on a mouth swab of the children, that is a painless non-invasive procedure.', 'armGroupLabels': ['Common HLA antigens with the lung donor', 'No common HLA antigens with the lung donor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire Atlantique', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle DANNER-BOUCHER', 'role': 'CONTACT', 'email': 'Isabelle.danner@chu-nantes.fr', 'phone': '+33 2 40 16 52 67'}, {'name': 'Angélique LECLERC', 'role': 'CONTACT', 'email': 'angelique.leclerc@chu-nantes.fr'}], 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie MACEY, PH', 'role': 'CONTACT', 'email': 'julie.macey@chu-bordeaux.fr', 'phone': '33 5 57 65 63 38'}], 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '38700', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christel SAINT-RAYMOND, PH', 'role': 'CONTACT', 'email': 'csaint-raymond@chu-grenoble.fr', 'phone': '33 4 76 76 75 93'}], 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '92350', 'city': 'Le Plessis-Robinson', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme LE PAVEC, PH', 'role': 'CONTACT', 'email': 'lepavec@gmail.com', 'phone': '33 1 40 94 24 30'}], 'facility': 'Marie Lannelongue Hospital (GHSJ)', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}, {'zip': '69002', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire MERVEILLEUX DU VIGNAUX, PH', 'role': 'CONTACT', 'email': 'claire.merveilleux@chu-lyon.fr', 'phone': '33 4 27 85 77 00'}], 'facility': 'Civils Hospitals Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Martine-Louise REYNAUD, PU-PH', 'role': 'CONTACT', 'email': 'martinelouise.reynaud@ap-hm.fr', 'phone': '33 4 91 96 61 45'}], 'facility': 'AP-HM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre-régis BURGEL, PU-PH', 'role': 'CONTACT', 'email': 'pierre-regis.burgel@aphp.fr', 'phone': '33 1 58 41 21 55'}], 'facility': 'Cochin Hospital (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67200', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain KESSLER, PU-PH', 'role': 'CONTACT', 'email': 'romain.kessler@chu-strasbourg.fr', 'phone': '33 3 69 55 06 45'}], 'facility': 'Strasbourg University Hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '92150', 'city': 'Suresnes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier BRUGIERE, PU-PH', 'role': 'CONTACT', 'email': 'o.brugiere@hopital-foch.com', 'phone': '33 1 46 25 38 01'}], 'facility': 'Foch Hospital', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'centralContacts': [{'name': 'Isabelle DANNER-BOUCHER', 'role': 'CONTACT', 'email': 'Isabelle.danner@chu-nantes.fr', 'phone': '+33 2 40 16 52 67'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut de Recherche en Santé Respiratoire', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}