Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT00960895
Status:
COMPLETED
Last Update Posted:
2011-10-27
First Post:
2009-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Hypertension in Lymphangioleiomyomatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018192', 'term': 'Lymphangioleiomyomatosis'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008203', 'term': 'Lymphangiomyoma'}, {'id': 'D018190', 'term': 'Neoplasm, Lymphatic Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054973', 'term': 'Perivascular Epithelioid Cell Neoplasms'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-26', 'studyFirstSubmitDate': '2009-08-17', 'studyFirstSubmitQcDate': '2009-08-17', 'lastUpdatePostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lymphangioleiomyomatosis', 'Pulmonary hypertension'], 'conditions': ['Lymphangioleiomyomatosis', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension.', 'detailedDescription': 'Descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension This will include modality of diagnosis of lLymphangioleiomyomatosis, results of right-sided heart catheterization, and pulmonary function tests'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lymphangioleiomyomatosis, either sporadic or associated with tuberous sclerosis Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lymphangioleiomyomatosis (definite or probable), either sporadic or associated with tuberous sclerosis\n* Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units)\n\nExclusion Criteria:\n\n* Post capillary pulmonary hypertension\n* Other identifiable causes of pulmonary hypertension (ex: thromboembolic disease)\n* Not willing to participate'}, 'identificationModule': {'nctId': 'NCT00960895', 'acronym': 'LAM-PH', 'briefTitle': 'Pulmonary Hypertension in Lymphangioleiomyomatosis', 'organization': {'class': 'OTHER', 'fullName': "Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires"}, 'officialTitle': 'Observational Study of Patients With Lymphangioleiomyomatosis and Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'GERMOP-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Lyon', 'state': 'University of Lyon', 'country': 'France', 'facility': 'Louis Pradel Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Vincent Cottin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Pr Cottin, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires", 'investigatorFullName': 'Vincent COTTIN', 'investigatorAffiliation': "Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires"}}}}