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

Bronchogenic Carcinoma Clinical Trial

— BOOST  

Official title:

A Randomized Controlled Trial of Endobronchial or Endoscopic Ultrasound as a First Test in the Diagnosis and Staging of Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652769
• Other study ID #: 07/0156
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2008
• Last updated: October 31, 2017
• Start date: March 2008
• Est. completion date: July 2012

Study information

• Verified date: October 2017
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: July 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchogenic Carcinoma
• Carcinoma, Bronchogenic

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United Kingdom	Barnet General Hospital	London
United Kingdom	North Middlesex University Hospital	London
United Kingdom	University College London Hospital NHS Trust	London
United Kingdom	Whittington Hospital NHS Trust	London

Sponsors (4)

Lead Sponsor	Collaborator
University College London Hospitals	Barnet and Chase Farm Hospitals NHS Trust, North Middlesex University Hospital, The Whittington Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. Epub 2007 Apr 19. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from first outpatient appointment to decision to treat		1 - 3 months
Secondary	The healthcare costs for diagnosing and staging lung cancer		End of study
Secondary	The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer		1 - 3 months
Secondary	The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan		1 - 3 months
Secondary	The time from first outpatient appointment to treatment		1 - 3 months
Secondary	The number of futile thoracotomies		1 - 3 years