Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT01791166
Status:
COMPLETED
Last Update Posted:
2016-09-12
First Post:
2013-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immuno-humoral Rejection Markers in Pulmonary Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-09', 'studyFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2013-02-12', 'lastUpdatePostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers.', 'timeFrame': '12 months after pulmonary transplant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Transplant']}, 'descriptionModule': {'briefSummary': 'Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders, more than 18 years of age.\n* Patients with or without Cystic fibrosis\n* Patients with no previous unilateral or bilateral pulmonary transplant or cardiopulmonary transplant\n* Patients with no current other disease can affect, in short term, the process or prognosis of the transplant\n* Patients had given his agreement to be enrolled in the study\n\nExclusion Criteria:\n\n* Patient less than 18 year-old\n* Patient had previous organ transplant\n* Pregnant and/or lactating women\n* Female subject in reproductive age does not use effective contraceptive methode\n* Alcoholisms or neuropsychosis, conditions that affect the good comprehension of the study'}, 'identificationModule': {'nctId': 'NCT01791166', 'acronym': 'RHUM-TP', 'briefTitle': 'Immuno-humoral Rejection Markers in Pulmonary Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Humoral Rejection - Diagnostic Markers in Pulmonary Transplant.', 'orgStudyIdInfo': {'id': '2010/49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary transplant', 'interventionNames': ['Biological: Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests']}], 'interventions': [{'name': 'Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Pulmonary transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92150', 'city': 'Suresnes', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hôpital FOCH', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}