Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2026-05-22 @ 10:13 PM
Study NCT ID:
NCT03702257
Status:
RECRUITING
Last Update Posted:
2022-02-14
First Post:
2018-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DSA Intragraft in Lung Transplantation: Diagnostic and Prognostic Value in Antibody Mediated Rejection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001999', 'term': 'Bronchoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2026-02-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-11', 'studyFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2018-10-08', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of AMR', 'timeFrame': '2 years', 'description': 'Sensitivity and specificity of the presence of gDSA for the diagnosis of AMR in lung transplant recipients with circulating DSA, as established by an expert pathologist panel and in accordance with recent international recommendations'}], 'secondaryOutcomes': [{'measure': 'Comparaison in gDSA+ vs gDSAs- patients', 'timeFrame': '2 years', 'description': 'Incidence of graft loss'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Transplant Recipient', 'Donor Specific Antibodies', 'Antibody Mediated Rejection']}, 'descriptionModule': {'briefSummary': 'The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria.\n\nHypothesis: the presence of intragraft donor specific antibodies (gDSAs) could be used as a new diagnostic tool for AMR in lung transplant recipients Study Objectives: to evaluate, in lung transplant patients with circulating DSAs, the diagnostic value of gDSAs in AMR and to analyze its prognostic value on graft outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient older than 18 years\n* Transplanted pulmonary or cardiopulmonary patient\n* And developing circulating anti-HLA antibodies directed against the graft or "DSA" at a threshold \\> 1000 of MFI in the 30 days preceding the inclusion visit\n* Affiliation to the French social security\n* Patient able to understand the objectives and risks related to research and to give informed, dated and signed consent\n\nExclusion criteria:\n\n* Patient whose anti-HLA antibodies are not directed against the graft (no DSA)\n* Contraindication to performing a bronchial fibroscopy with transbronchial biopsies\n* Treatment with intravenous immunoglobulin (less than 1 month before inclusion) or Rituximab (less than 6 months before inclusion)\n* Plasma exchanges (less than 3 months before inclusion)\n* Risk of bleeding predictable (crushing disorder, impossibility of stopping the offending treatments)\n* Impossibility of giving the subject informed information\n* Subject under the protection of justice Subject under guardianship or curatorship\n* Pregnancy\n* Breastfeeding'}, 'identificationModule': {'nctId': 'NCT03702257', 'briefTitle': 'DSA Intragraft in Lung Transplantation: Diagnostic and Prognostic Value in Antibody Mediated Rejection', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': "Intérêt Diagnostique et Pronostique de la présence d'Anticorps spécifiques du Donneur Intra-greffon Dans le Rejet Humoral en Transplantation Pulmonaire", 'orgStudyIdInfo': {'id': '7039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bronchial fibroscopy', 'description': 'Bronchial fibroscopy with trans-bronchial biopsies', 'interventionNames': ['Procedure: bronchoscopy.']}], 'interventions': [{'name': 'bronchoscopy.', 'type': 'PROCEDURE', 'description': 'gDSAs are studied on cryopreserved biopsies obtained during bronchoscopy. The technique is the one described by Visentin J.', 'armGroupLabels': ['Bronchial fibroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Le Plessis-Robinson', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme LE PAVEC', 'role': 'CONTACT', 'email': 'lepavec@gmail.com', 'phone': '+33 1 40 94 24 30'}], 'facility': 'Hôpital Marie Lannelongue', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}, {'zip': '13915', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Martine REYNAUD GAUBERT', 'role': 'CONTACT', 'email': 'martine.reynaud@ap-hm.fr', 'phone': '+33 1 40 25 82 37'}], 'facility': 'CHU Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75018', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier BRUGIERE', 'role': 'CONTACT', 'email': 'olivier.brugiere@aphp.fr', 'phone': '+33 1 40 25 82 37'}], 'facility': 'Hôpital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandrine HIRSCHI', 'role': 'CONTACT', 'email': 'sandrine.hirschi@chru-strasbourg.fr', 'phone': '+33 3 69 55 11 78'}, {'name': 'Sandrine HIRSCHI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '92151', 'city': 'Suresnes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine ROUX', 'role': 'CONTACT', 'email': 'a.roux@hopital-foch.org', 'phone': '+33 1 46 25 37 31'}], 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'centralContacts': [{'name': 'Sandrine HIRSCHI', 'role': 'CONTACT', 'email': 'sandrine.hirschi@chru-strasbourg.fr', 'phone': '+33 3 69 55 11 78'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}