Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT00982605
Status:
UNKNOWN
Last Update Posted:
2009-10-06
First Post:
2009-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes (LN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'lymph nodes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-05', 'studyFirstSubmitDate': '2009-09-22', 'studyFirstSubmitQcDate': '2009-09-22', 'lastUpdatePostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '18519953', 'type': 'BACKGROUND', 'citation': 'Herth FJ, Annema JT, Eberhardt R, Yasufuku K, Ernst A, Krasnik M, Rintoul RC. Endobronchial ultrasound with transbronchial needle aspiration for restaging the mediastinum in lung cancer. J Clin Oncol. 2008 Jul 10;26(20):3346-50. doi: 10.1200/JCO.2007.14.9229. Epub 2008 Jun 2.'}, {'pmid': '17206430', 'type': 'BACKGROUND', 'citation': 'Herth FJ, Eberhardt R. Actual role of endobronchial ultrasound (EBUS). Eur Radiol. 2007 Jul;17(7):1806-12. doi: 10.1007/s00330-006-0497-6. Epub 2007 Jan 6.'}, {'pmid': '16807262', 'type': 'BACKGROUND', 'citation': 'Herth FJ, Ernst A, Eberhardt R, Vilmann P, Dienemann H, Krasnik M. Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically normal mediastinum. Eur Respir J. 2006 Nov;28(5):910-4. doi: 10.1183/09031936.06.00124905. Epub 2006 Jun 28.'}, {'pmid': '16738038', 'type': 'BACKGROUND', 'citation': 'Herth FJ, Eberhardt R, Vilmann P, Krasnik M, Ernst A. Real-time endobronchial ultrasound guided transbronchial needle aspiration for sampling mediastinal lymph nodes. Thorax. 2006 Sep;61(9):795-8. doi: 10.1136/thx.2005.047829. Epub 2006 May 31.'}, {'pmid': '16417559', 'type': 'BACKGROUND', 'citation': 'Al-Haddad M, Wallace MB. Molecular diagnostics of non-small cell lung cancer using mediastinal lymph nodes sampled by endoscopic ultrasound-guided needle aspiration. Cytopathology. 2006 Feb;17(1):3-9. doi: 10.1111/j.1365-2303.2006.00318.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle aspiration (EBUS-TBNA).', 'detailedDescription': 'NSCLC is a common cancer. Accurate and early staging has a significant impact on outcome. EBUS-TBNA of involved mediastinal lymph nodes is critical. Molecular markers could improve mediastinal staging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with operable non-small cell lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Samples are collected before surgery or before any therapy\n* ECOG 0 or 1\n* Clinical stage I-II, T1-2, N0-1, M0)\n* Surgically respectable\n* Patient with enlarged med. lymphnodes (control group)\n\nExclusion Criteria:\n\n* Previous RT/CHT\n* Previous or current cancer of other entity'}, 'identificationModule': {'nctId': 'NCT00982605', 'briefTitle': 'EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes (LN)', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes', 'orgStudyIdInfo': {'id': 'MK01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non small cell lung cancer', 'description': 'cancer patients', 'interventionNames': ['Procedure: EBUS_TBNA']}], 'interventions': [{'name': 'EBUS_TBNA', 'type': 'PROCEDURE', 'otherNames': ['EBUS-TBNA scope, Olympus Medical'], 'description': 'EBUS during bronchoscopy', 'armGroupLabels': ['non small cell lung cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69126', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Kreuter, MD', 'role': 'CONTACT', 'email': 'michael.kreuter@thoraxklinik-heidelberg.de', 'phone': '49 / 6221 / 396', 'phoneExt': '1201'}], 'facility': 'Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Michael Kreuter, MD', 'role': 'CONTACT', 'email': 'michael.kreuter@thoraxklinik-heidelberg.de', 'phone': '49 / 6221 / 396', 'phoneExt': '1201'}], 'overallOfficials': [{'name': 'Michael Kreuter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Thoraxklinik Heidelberg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Felix Herth', 'oldOrganization': 'Thoraxklinik Heidelberg'}}}}