Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-22 @ 4:47 AM
Study NCT ID:
NCT02157194
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2014-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endobronchial Ultrasound-transbronchial Needle Aspiration (EBUS-TBNA) Sample Division
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2014-06-01', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity of lung cancer diagnosis', 'timeFrame': '6 month', 'description': 'We aim to evaluate if splitting the obtained specimen will have an impact on lung cancer diagnosis performed by histopathologic analysis'}], 'secondaryOutcomes': [{'measure': 'Percentage of successful performed molecular RNA based analysis', 'timeFrame': '3 month', 'description': 'We will analyse the second half of the sample regarding molecular analysis. RNA concentration and RNA integrity score will be assessed before a new RNA based test will be evaluated.'}]}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular analysis. The purpose of this study is to evaluate if samples from on lymph node site can be divided for diagnosis and molecular analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects suspected to have lung cancer and enlarged mediastinal lymph nodes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of lung cancer\n* enlarged mediastinal or hilar lymph nodes (\\>10 mm)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02157194', 'briefTitle': 'Endobronchial Ultrasound-transbronchial Needle Aspiration (EBUS-TBNA) Sample Division', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'orgStudyIdInfo': {'id': 'RLK-EBUS-2'}, 'secondaryIdInfos': [{'id': '11-4921-BO', 'type': 'OTHER', 'domain': 'EC UK Essen'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Essen', 'country': 'Germany', 'facility': 'Ruhrlandklinik-UK Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Physician Interventional Pneumology', 'investigatorFullName': 'Kaid Darwiche', 'investigatorAffiliation': 'University Hospital, Essen'}}}}