Clinical trial NCT00652769: A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)
Official title: A Randomized Controlled Trial of Endobronchial or Endoscopic Ultrasound as a First Test in the Diagnosis and Staging of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchogenic Carcinoma
Keywords: Lung
Cancer
Staging
Endobronchial
Ultrasound
Endoscopic
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: North Middlesex University Hospital
name: Barnet and Chase Farm Hospitals NHS Trust
name: The Whittington Hospital NHS Trust
First posted: 2008-04-04
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients suspected of lung cancer on CT scan
* Written informed consent
* Able to tolerate bronchoscopy and thoracic surgery

Exclusion Criteria:

* Evidence of severe or uncontrolled systemic disease that makes it undesirable for the patient to participate in the trial
* Any disorder making reliable informed consent impossible
* Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion

Primary outcomes:
measure: Time from first outpatient appointment to decision to treat
timeFrame: 1 - 3 months
Secondary outcomes:
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
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barnet General Hospital
city: London
country: United Kingdom
facility: North Middlesex University Hospital
city: London
country: United Kingdom
facility: Whittington Hospital NHS Trust
city: London
country: United Kingdom
facility: University College London Hospital NHS Trust
Study officials:
affiliation: Univeristy College London NHS Trust
name: Stephen Spiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Sam Janes, MD PhD
role: STUDY_CHAIR
affiliation: University College, London
name: Neal Navani, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.