A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)

Phase 3

Completed

• Conditions: Bronchogenic Carcinoma
• Interventions: Procedure: Endobronchial or Endoscopic Ultrasound; Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy

• Registration Number: NCT00652769
• Lead Sponsor: University College London Hospitals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-04
• Primary Completion: 2011-09
• Study Completion: 2012-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Endobronchial or Endoscopic Ultrasound	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.
B	Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy	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.

Primary Outcome Measures

Name	Time	Method
Time from first outpatient appointment to decision to treat	1 - 3 months

Secondary Outcome Measures

Name	Time	Method
The healthcare costs for diagnosing and staging lung cancer	End of study
The number of futile thoracotomies	1 - 3 years
The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer	1 - 3 months
The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan	1 - 3 months
The time from first outpatient appointment to treatment	1 - 3 months

Trial Locations

Locations (4)

Whittington Hospital NHS Trust; 🇬🇧 London, United Kingdom

Barnet General Hospital; 🇬🇧 London, United Kingdom

North Middlesex University Hospital; 🇬🇧 London, United Kingdom

University College London Hospital NHS Trust; 🇬🇧 London, United Kingdom