Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT00861835
Status:
COMPLETED
Last Update Posted:
2009-03-13
First Post:
2009-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate (TBNA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'DIAGNOSTIC'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-12', 'studyFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2009-03-12', 'lastUpdatePostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic yield'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bronchoscopy']}, 'descriptionModule': {'briefSummary': 'Purpose: Previous studies suggested an increased diagnostic yield for bronchoscopic (FB) transbronchial needle aspirate (TBNA) specimens from mediastinal lymph nodes when using rapid on-site evaluation by cytopathology (ROSE) but were limited by lack of randomization. The investigators performed the first randomized-prospective trial comparing ROSE(R) to no on-site cytopathology assessment (NR).\n\nMethods: All patients referred were eligible. 78 patients were randomized to R or NR groups. For R procedures, further specimens were deferred until results were available from the on-site cytopathologist. Diagnoses made by all procedures were recorded. The primary end-points were specimen adequacy and diagnostic yield.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients included all adults referred for bronchoscopy with anticipated TBNA.\n\nExclusion Criteria:\n\n* Patients were to be excluded only if the attending physician felt ROSE must be used for diagnosis or if the patient refused consent.'}, 'identificationModule': {'nctId': 'NCT00861835', 'briefTitle': 'Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate (TBNA)', 'organization': {'class': 'OTHER', 'fullName': 'MaineHealth'}, 'officialTitle': 'A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens', 'orgStudyIdInfo': {'id': 'MMCROSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ROSE for TBNA', 'interventionNames': ['Other: ROSE']}, {'type': 'NO_INTERVENTION', 'label': 'NR', 'description': 'no on-site cytopathology assessment (NR)'}], 'interventions': [{'name': 'ROSE', 'type': 'OTHER', 'description': 'rapid on-site evaluation by cytopathology', 'armGroupLabels': ['ROSE for TBNA']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MaineHealth', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Lonny Yarmus, DO', 'oldOrganization': 'Maine Medical Center'}}}}