Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
Study NCT ID:
NCT00700934
Status:
UNKNOWN
Last Update Posted:
2010-12-07
First Post:
2008-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019896', 'term': 'alpha 1-Antitrypsin Deficiency'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013352', 'term': 'Subcutaneous Emphysema'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-06', 'studyFirstSubmitDate': '2008-06-18', 'studyFirstSubmitQcDate': '2008-06-18', 'lastUpdatePostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FEV1', 'mortality', 'Quality of life'], 'conditions': ['Alpha 1-Antitrypsin Deficiency', 'Emphysema']}, 'referencesModule': {'references': [{'pmid': '25938292', 'type': 'DERIVED', 'citation': 'Gauvain C, Mornex JF, Pison C, Cuvelier A, Balduyck M, Pujazon MC, Fournier M, AitIlalne B, Thabut G. Health-related quality of life in patients with alpha-1 antitrypsin deficiency: the French experience. COPD. 2015 May;12 Suppl 1:46-51. doi: 10.3109/15412555.2015.1022645.'}, {'pmid': '24525449', 'type': 'DERIVED', 'citation': 'Thabut G, Mornex JF, Pison C, Cuvelier A, Balduyck M, Pujazon MC, Fournier M, AitIlalne B, Porcher R. Performance of the BODE index in patients with alpha1-antitrypsin deficiency-related COPD. Eur Respir J. 2014 Jul;44(1):78-86. doi: 10.1183/09031936.00168113. Epub 2014 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe the natural history of patients with alpha-1 antitrypsin associated emphysema and to figure out associated prognostic factors.', 'detailedDescription': "All patients who suffer from this disease are followed every 6 months during a 5 years period. FEV1 decline is the primary endpoint. Quality of life assessed using the Saint George's Respiratory Questionary is recorded too."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Emphysema associated alpha-1 antitrypsin deficiency', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Serum alpha one antitrypsin \\< 0.8 g/l\n* Emphysema diagnosed by CT scan\n* Adult\n* Obstructive disorder\n\nExclusion Criteria:\n\n* Liver or lung transplantation'}, 'identificationModule': {'nctId': 'NCT00700934', 'briefTitle': 'Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema. A National Registry.', 'orgStudyIdInfo': {'id': '001'}}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gabriel Thabut, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Departement d'épidémiologie, Hôpital Bichat", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Gabriel Thabut, MD', 'role': 'CONTACT', 'email': 'g.thabut@bch.aphp.fr', 'phone': '1 40 87 57 12'}], 'overallOfficials': [{'name': 'Gabriel Thabut, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Docteur Gabriel Thabut', 'oldOrganization': 'Assistance Publique Hopitaux de Paris'}}}}