Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-28 @ 3:31 PM
Study NCT ID:
NCT01653002
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2012-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methylation Level of SHOX2 in Endobronchial Ultrasound With Real-time Guided Transbronchial Needle Aspiration for Lung Cancer Staging
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2012-07-23', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Performance of SHOX2', 'timeFrame': 'one Year', 'description': 'Diagnostic performance of SHOX2 methylation Level as biomarker for lung cancer compared to histologic evaluation of EBUS-TBNA specimen alone.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung cancer', 'EBUS-TBNA', 'Epigenetics', 'shox2 protein, human'], 'conditions': ['Lung Cancer With Mediastinal Lymph Node Involvement']}, 'descriptionModule': {'briefSummary': 'A DNA hypermethylation of the gene locus SHOX2 can be frequently found in lung cancer tissue. The purpose of this study is to determine whether the assessment of the hypermethylation level of SHOX2 in specimens obtained by endosonographic guided bronchoscopy makes a contribution to lung cancer staging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with proven or suspcted lung cancer and enlarged mediastinal or hilar 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* clinical condition which excludes general anesthesia'}, 'identificationModule': {'nctId': 'NCT01653002', 'briefTitle': 'Methylation Level of SHOX2 in Endobronchial Ultrasound With Real-time Guided Transbronchial Needle Aspiration for Lung Cancer Staging', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'orgStudyIdInfo': {'id': 'RLK-Epi-1'}, 'secondaryIdInfos': [{'id': '11-4921-BO', 'type': 'OTHER', 'domain': 'Ethical Review Board University Clinic Essen'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung cancer with lymph node involvement', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['Lung cancer with lymph node involvement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45239', 'city': 'Essen', 'country': 'Germany', 'facility': 'Ruhrlandklinik - Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Epigenomics, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Kaid Darwiche', 'investigatorFullName': 'Kaid Darwiche', 'investigatorAffiliation': 'University Hospital, Essen'}}}}