A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)
NCT ID: NCT00652769
Last Updated: 2017-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2008-03-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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B
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.
Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy
Investigations will be determined by the multi-disciplinary team responsible for the patient
A
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.
Endobronchial or Endoscopic Ultrasound
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.
Interventions
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Endobronchial or Endoscopic Ultrasound
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.
Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy
Investigations will be determined by the multi-disciplinary team responsible for the patient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Able to tolerate bronchoscopy and thoracic surgery
Exclusion Criteria
* Any disorder making reliable informed consent impossible
* Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion
18 Years
ALL
No
Sponsors
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North Middlesex University Hospital
OTHER
Barnet and Chase Farm Hospitals NHS Trust
OTHER
The Whittington Hospital NHS Trust
OTHER_GOV
University College London Hospitals
OTHER
Responsible Party
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Sam Janes
Reader in Respiratory Medicine
Principal Investigators
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Stephen Spiro, MD
Role: PRINCIPAL_INVESTIGATOR
Univeristy College London NHS Trust
Sam Janes, MD PhD
Role: STUDY_CHAIR
University College, London
Neal Navani, MD
Role: STUDY_DIRECTOR
University College, London
Locations
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Barnet General Hospital
London, , United Kingdom
North Middlesex University Hospital
London, , United Kingdom
Whittington Hospital NHS Trust
London, , United Kingdom
University College London Hospital NHS Trust
London, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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07/0156
Identifier Type: -
Identifier Source: org_study_id