Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-04 @ 8:00 AM
Study NCT ID:
NCT00652769
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001999', 'term': 'Bronchoscopy'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D008481', 'term': 'Mediastinoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from first outpatient appointment to decision to treat', 'timeFrame': '1 - 3 months'}], 'secondaryOutcomes': [{'measure': 'The healthcare costs for diagnosing and staging lung cancer', 'timeFrame': 'End of study'}, {'measure': 'The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer', 'timeFrame': '1 - 3 months'}, {'measure': 'The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan', 'timeFrame': '1 - 3 months'}, {'measure': 'The time from first outpatient appointment to treatment', 'timeFrame': '1 - 3 months'}, {'measure': 'The number of futile thoracotomies', 'timeFrame': '1 - 3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung', 'Cancer', 'Staging', 'Endobronchial', 'Ultrasound', 'Endoscopic'], 'conditions': ['Bronchogenic Carcinoma']}, 'referencesModule': {'references': [{'pmid': '11809983', 'type': 'BACKGROUND', 'citation': 'Herder GJ, Verboom P, Smit EF, van Velthoven PC, van den Bergh JH, Colder CD, van Mansom I, van Mourik JC, Postmus PE, Teule GJ, Hoekstra OS. Practice, efficacy and cost of staging suspected non-small cell lung cancer: a retrospective study in two Dutch hospitals. Thorax. 2002 Jan;57(1):11-4. doi: 10.1136/thorax.57.1.11.'}, {'pmid': '17873169', 'type': 'BACKGROUND', 'citation': 'Detterbeck FC, Jantz MA, Wallace M, Vansteenkiste J, Silvestri GA; American College of Chest Physicians. Invasive mediastinal staging of lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):202S-220S. doi: 10.1378/chest.07-1362.'}, {'pmid': '17873168', 'type': 'BACKGROUND', 'citation': 'Silvestri GA, Gould MK, Margolis ML, Tanoue LT, McCrory D, Toloza E, Detterbeck F; American College of Chest Physicians. Noninvasive staging of non-small cell lung cancer: ACCP evidenced-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):178S-201S. doi: 10.1378/chest.07-1360.'}, {'pmid': '17448671', 'type': 'BACKGROUND', 'citation': 'De Leyn P, Lardinois D, Van Schil PE, Rami-Porta R, Passlick B, Zielinski M, Waller DA, Lerut T, Weder W. ESTS guidelines for preoperative lymph node staging for non-small cell lung cancer. Eur J Cardiothorac Surg. 2007 Jul;32(1):1-8. doi: 10.1016/j.ejcts.2007.01.075. Epub 2007 Apr 19.'}, {'pmid': '17277288', 'type': 'BACKGROUND', 'citation': 'Janes SM, Spiro SG. Esophageal endoscopic ultrasound/endobronchial ultrasound-guided fine needle aspiration: a new dawn for the respiratory physician? Am J Respir Crit Care Med. 2007 Feb 15;175(4):297-9. doi: 10.1164/rccm.200609-1390ED. No abstract available.'}, {'pmid': '19390554', 'type': 'BACKGROUND', 'citation': 'Navani N, Spiro SG, Janes SM. Mediastinal staging of NSCLC with endoscopic and endobronchial ultrasound. Nat Rev Clin Oncol. 2009 May;6(5):278-86. doi: 10.1038/nrclinonc.2009.39.'}, {'pmid': '25660225', 'type': 'DERIVED', 'citation': 'Navani N, Nankivell M, Lawrence DR, Lock S, Makker H, Baldwin DR, Stephens RJ, Parmar MK, Spiro SG, Morris S, Janes SM; Lung-BOOST trial investigators. Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial. Lancet Respir Med. 2015 Apr;3(4):282-9. doi: 10.1016/S2213-2600(15)00029-6. Epub 2015 Feb 4.'}]}, 'descriptionModule': {'briefSummary': "In the UK, staging of lung cancer is time consuming (taking on average more than 3 weeks), costly and inaccurate in up to 20% of cases. The investigators wish to determine whether using the newer techniques of endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) improves lung cancer staging. The investigators' hypothesis is that EUS (endoscopic ultrasound) or EBUS (endobronchial ultrasound guided transbronchial needle aspirate) as a first test after CT scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient appointment to treatment decision, a reduction in the total number of scans and investigative operations, fewer outpatient attendances and a reduction in healthcare costs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients suspected of lung cancer on CT scan\n* Written informed consent\n* Able to tolerate bronchoscopy and thoracic surgery\n\nExclusion Criteria:\n\n* Evidence of severe or uncontrolled systemic disease that makes it undesirable for the patient to participate in the trial\n* Any disorder making reliable informed consent impossible\n* Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion'}, 'identificationModule': {'nctId': 'NCT00652769', 'acronym': 'BOOST', 'briefTitle': 'A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)', 'organization': {'class': 'OTHER', 'fullName': 'University College London Hospitals'}, 'officialTitle': 'A Randomized Controlled Trial of Endobronchial or Endoscopic Ultrasound as a First Test in the Diagnosis and Staging of Lung Cancer', 'orgStudyIdInfo': {'id': '07/0156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Control arm: Current practice for diagnosing and staging lung cancer. Most patients with intra-thoracic disease suspected of lung cancer will undergo bronchoscopy (or CT guided biopsy), PET scan and possibly mediastinoscopy.', 'interventionNames': ['Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Active arm: A new pathway for the diagnosis and staging of lung cancer with endobronchial (EBUS) or endoscopic ultrasound (EUS) as a first test. If EBUS or EUS is negative the patient will have PET scan +/- mediastinoscopy.', 'interventionNames': ['Procedure: Endobronchial or Endoscopic Ultrasound']}], 'interventions': [{'name': 'Endobronchial or Endoscopic Ultrasound', 'type': 'PROCEDURE', 'otherNames': ['EBUS: Olympus Keymed BF-UC260F-OL8'], 'description': 'Patients with anterior mediastinal or subcarinal disease will undergo EBUS. Patients with posterior, subcarinal or AP window disease will undergo EUS. Patients with no mediastinal disease on CT scan will undergo EBUS.', 'armGroupLabels': ['A']}, {'name': 'Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy', 'type': 'PROCEDURE', 'description': 'Investigations will be determined by the multi-disciplinary team responsible for the patient', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EN5 3DJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barnet General Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'N18 1QX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'North Middlesex University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'N19 5NF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Whittington Hospital NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1E 6AU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospital NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Stephen Spiro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy College London NHS Trust'}, {'name': 'Sam Janes, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University College, London'}, {'name': 'Neal Navani, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University College, London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College London Hospitals', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Middlesex University Hospital', 'class': 'OTHER'}, {'name': 'Barnet and Chase Farm Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'The Whittington Hospital NHS Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reader in Respiratory Medicine', 'investigatorFullName': 'Sam Janes', 'investigatorAffiliation': 'University College London Hospitals'}}}}