Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-06 @ 6:21 PM
Study NCT ID:
NCT02157857
Status:
UNKNOWN
Last Update Posted:
2014-06-06
First Post:
2014-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Step Nucleic Acid Amplification in Endobronchial Ultrasound-guided Needle Aspiration Samples
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-11-17', 'releaseDate': '2015-10-13'}, {'resetDate': '2017-01-18', 'releaseDate': '2016-11-23'}], 'estimatedResultsFirstSubmitDate': '2015-10-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Endobronchial ultrasound-guided needle-aspiration samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-05', 'studyFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2014-06-05', 'lastUpdatePostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One step nucleic acid amplification of Cytokeratin 19 mRNA', 'timeFrame': '6 months', 'description': 'One step nucleic acid amplification of Cytokeratin 19 mRNA, copy number detection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NSCLC, SCLC, lung cancer, EBUS-TBNA'], 'conditions': ['Lung Neoplasms']}, 'referencesModule': {'references': [{'pmid': '21963329', 'type': 'BACKGROUND', 'citation': 'Yasufuku K, Pierre A, Darling G, de Perrot M, Waddell T, Johnston M, da Cunha Santos G, Geddie W, Boerner S, Le LW, Keshavjee S. A prospective controlled trial of endobronchial ultrasound-guided transbronchial needle aspiration compared with mediastinoscopy for mediastinal lymph node staging of lung cancer. J Thorac Cardiovasc Surg. 2011 Dec;142(6):1393-400.e1. doi: 10.1016/j.jtcvs.2011.08.037. Epub 2011 Oct 2.'}, {'pmid': '23026640', 'type': 'BACKGROUND', 'citation': 'Inoue M, Hiyama K, Nakabayashi K, Morii E, Minami M, Sawabata N, Shintani Y, Nakagiri T, Susaki Y, Maeda J, Higashiyama M, Okami J, Yoshida Y, Ding J, Otomo Y, Okumura M. An accurate and rapid detection of lymph node metastasis in non-small cell lung cancer patients based on one-step nucleic acid amplification assay. Lung Cancer. 2012 Dec;78(3):212-8. doi: 10.1016/j.lungcan.2012.08.018. Epub 2012 Sep 29.'}, {'pmid': '24331309', 'type': 'BACKGROUND', 'citation': 'Babar M, Madani R, Thwaites L, Jackson PA, Devalia HL, Chakravorty A, Irvine TE, Layer GT, Kissin MW. A differential intra-operative molecular biological test for the detection of sentinel lymph node metastases in breast carcinoma. An extended experience from the first U.K. centre routinely offering the service in clinical practice. Eur J Surg Oncol. 2014 Mar;40(3):282-8. doi: 10.1016/j.ejso.2013.10.030. Epub 2013 Nov 21.'}, {'pmid': '26455862', 'type': 'DERIVED', 'citation': 'Oezkan F, Khan AM, Hager T, Freitag L, Christoph D, Darwiche K. OSNA: A Fast Molecular Test Based on CK19 mRNA Concentration for Assessment of EBUS-TBNA Samples in Lung Cancer Patients. Clin Lung Cancer. 2016 May;17(3):198-204. doi: 10.1016/j.cllc.2015.09.001. Epub 2015 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to investigate if CK19 mRNA-detection via OSNA can accurately detect lymph node metastases in lung cancer patients using EBUS-TBNA samples.', 'detailedDescription': 'Regional lymph nodes are assessed before tumor resection and before initiation of chemo- or radiotherapy. Endobronchial ultrasound-guided needle aspiration (EBUS-TBNA) is a well-established method for mediastinal and hilar lymph node staging \\[2, 3\\]. Samples obtained via this route are much smaller than surgical lymph node biopsies, yet they are able to provide complete and thorough evaluation, this includes current molecular testing.\n\nOne Step Nucleic Acid Amplification (OSNA), a molecular test that utilizes CK 19 mRNA-concentration as a target marker is becoming a rapidly dynamic method in quick detection of sentinel lymph node (SLN) metastases in breast cancer, colon cancer and other cancers.\n\nIn lung cancer, the role of SLN is not well established. However, recent publications suggest an accurate and rapid detection of lymph node metastases in NSCLC. However this requires complete lymph node dissection either with mediastinoscopy or by other surgical means such as thoracotomy.\n\nThe aim of our study is to investigate if CK19 mRNA-detection via OSNA can accurately detect lymph node metastases in lung cancer patients using EBUS-TBNA samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CT-scans suspicious for primary diagnosis of lung cancer and enlarged mediastinal lymph nodes Patients with known diagnosis of lung cancer and newly enlarged mediastinal lymph nodes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CT-scan suspicious for lung cancer,\n* enlarged mediastinal lymph nodes (\\>10 mm),\n* EBUS-TBNA to be performed,\n* age: 18-99 years\n\nExclusion Criteria:\n\n* age: \\<18 years'}, 'identificationModule': {'nctId': 'NCT02157857', 'briefTitle': 'One Step Nucleic Acid Amplification in Endobronchial Ultrasound-guided Needle Aspiration Samples', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': 'A Molecular Test for Rapid On-site Evaluation in EBUS-TBNAsamples of Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'OSNA in EBUS-TBNA'}}, 'contactsLocationsModule': {'locations': [{'zip': '45239', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Filiz Oezkan, MD', 'role': 'CONTACT', 'email': 'filiz.oezkan@ruhrlandklinik.uk-essen.de', 'phone': '00492014334634'}, {'name': 'Kaid Darwiche, MD', 'role': 'CONTACT', 'email': 'kaid.darwiche@ruhrlandklinik.uk-essen.de', 'phone': '00492014334552'}, {'name': 'Filiz Oezkan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruhrlandklinik', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'centralContacts': [{'name': 'Filiz Oezkan, MD', 'role': 'CONTACT', 'email': 'filiz.oezkan@ruhrlandklinik.uk-essen.de', 'phone': '00492014334634'}, {'name': 'Kaid Darwiche, MD', 'role': 'CONTACT', 'email': 'kaid.darwiche@ruhrlandklinik.uk-essen.de', 'phone': '00492014334552'}], 'overallOfficials': [{'name': 'Kaid Darwiche, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Essen'}, {'name': 'Filiz Oezkan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Filiz Oezkan', 'investigatorFullName': 'Filiz Oezkan', 'investigatorAffiliation': 'University Hospital, Essen'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-10-13', 'type': 'RELEASE'}, {'date': '2015-11-17', 'type': 'RESET'}, {'date': '2016-11-23', 'type': 'RELEASE'}, {'date': '2017-01-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Filiz Oezkan, Dr. med. Filiz Oezkan, University Hospital, Essen'}}}}