Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 1:39 AM
Study NCT ID:
NCT07350356
Status:
COMPLETED
Last Update Posted:
2026-01-20
First Post:
2025-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bronchoscopic Role in Early Detection of Endobronchial Tuberculosis in Suspected Pulmonary Tuberculosis Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'targetDuration': '10 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-14', 'studyFirstSubmitDate': '2025-12-20', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the role of fiberoptic bronchoscopy in sputum smear negative and radiologically suspected pulmonary tuberculosis 63 patients in Mansoura chest hospital, bronchoscopy unit for early detection of endobronchial tuberculosis.', 'timeFrame': '1 year', 'description': 'bronchoscopic evaluation of tracheobronchial tree for endobronchial tuberculosis lesions in patients with suspected PTB'}], 'secondaryOutcomes': [{'measure': 'The clinical presentation, bronchoscopic characteristics in comparison to radiological characteristics of EBTB, and incidence of EBTB subtypes in pulmonary TB patients', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fiberoptic bronchoscopy', 'Endobronchial TB', 'Smear negative TB', 'Suspected PTB'], 'conditions': ['Endobronchial Mass', 'Tuberculosis, Pulmonary']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the role of bronchoscopy in diagnosis of endobronchial tuberculosis in suspected pulmonary tuberculosis patients whose sputum samples are negative for Ziehl Neelsen stain.', 'detailedDescription': 'Bronchoscopy plays a major role in identification and diagnosis of EBTB. As a general principal, Bronchoscopy -associated with microbiological testing- must be performed on patients whose CT examination results indicate EBTB.\n\nThis study will try to focus on the importance of bronchoscopy in diagnosis of endobronchial tuberculosis among suspected pulmonary tuberculosis patients who undergo fiberoptic bronchoscope after being sputum Ziehl Neelsen negative, scarce sputum and/or persistent consolidation on chest radiograph (CXR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients will be recruited from Mansoura chest hospital for pulmonary tuberculosis suspected patients who are smear negative for acid fast bacilli.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* o Adults more than18 years.\n\n * Accept to participate.\n * Suspected pulmonary tuberculosis patients with three negative sputum samples are smear negative, and/or persistent consolidation on chest radiograph (CXR).\n\nExclusion Criteria:\n\n* o Patients who refuse to participate in the study.\n\n * Patients who are sputum Ziehl Neelsen positive.\n * Patients who are diagnosed extrapulmonary tuberculosis.\n * Patients who are not fit for bronchoscopy.'}, 'identificationModule': {'nctId': 'NCT07350356', 'briefTitle': 'Bronchoscopic Role in Early Detection of Endobronchial Tuberculosis in Suspected Pulmonary Tuberculosis Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Bronchoscopic Role in Early Detection of Endobronchial Tuberculosis in Undiagnosed Suspected Pulmonary Tuberculosis Patients.', 'orgStudyIdInfo': {'id': 'FMASU MD 203/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1: PTB with concomitant EBTB, group 2: PTB with no concomitant EBTB.', 'description': 'group 1of 41 patients had positive bronchoscopic findings of PTB with concomitant of EBTB, group 2 of 22 patients had PTB with no concomitant EBTB.', 'interventionNames': ['Diagnostic Test: fiberoptic bronchoscopy evaluation of endobronchial features of TB']}], 'interventions': [{'name': 'fiberoptic bronchoscopy evaluation of endobronchial features of TB', 'type': 'DIAGNOSTIC_TEST', 'description': "EBTB was classified into seven subtypes by using the Chung's method: actively caseating, fibrostenotic, oedematous-hyperaemic, tumorous, ulcerative, granular, and the non-specific bronchitic subtype.", 'armGroupLabels': ['group 1: PTB with concomitant EBTB, group 2: PTB with no concomitant EBTB.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11511', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Heba Shalaby', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Heba M Shalaby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University, Faculty of medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '1 year', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication maybe shared', 'accessCriteria': 'personal request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}