Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-01 @ 2:59 PM
Study NCT ID:
NCT01714934
Status:
UNKNOWN
Last Update Posted:
2012-10-26
First Post:
2012-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Gastric Content Microaspirations in the Pathogenesis of Idiopathic Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'BAL broncho alveolar lavage at bronchoscopy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-25', 'studyFirstSubmitDate': '2012-10-23', 'studyFirstSubmitQcDate': '2012-10-25', 'lastUpdatePostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BAL Pepsin level', 'timeFrame': '18 MONTHS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IDIOPATHIC PULMONARY FIBROSIS', 'MICROASPIRATION'], 'conditions': ['IDIOPATHIC PULMONARY FIBROSIS']}, 'descriptionModule': {'briefSummary': 'The pathogenesis of idiopathic pulmonary fibrosis (IPF) is debatable. Looking for an insult to lung parenchyma that generates the pathogenesis of the disease is challenging. Pepsin is a proteolytic enzyme present in the gastric juice. Microaspirations of gastric content were described as a potential factor for injury in many chronic lung disorders. Bronchoalveolar lavage (BAL) is a routine investigation technique in interstitial lung diseases. The presence of pepsin in the BAL fluid recovered from patients with IPF may indicate a possible role for gastric microaspirations in the pathogenesis of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with IPF versus patients with other interstitial lung disorders (non IPF)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with interstitial lung disorders including IPF\n\nExclusion Criteria:\n\n* patients younger than 18 years or older than 85,\n* pregnant women,\n* patients that present with medical conditions contra -indicated for performing bronchoscopy including sedation'}, 'identificationModule': {'nctId': 'NCT01714934', 'briefTitle': 'The Role of Gastric Content Microaspirations in the Pathogenesis of Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Study of Pepsin Levels in the Broncho-Alveolar-Lavage Fluid of Patients With Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'SHEBA-12-9440-TS-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IPF', 'description': 'IPF patients diagnosed according to clinical and radiological findings'}, {'label': 'NON IPF', 'description': 'Other interstitial lung diseases such as sarcoidosis or hypersensitivity pneumonitis diagnosed as per clinical and radiological findings'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}