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Completed

NCT Number: NCT00652769

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

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.

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Key information

Conditions

Bronchogenic Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Barnet General Hospital, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endobronchial or Endoscopic Ultrasound

Procedure

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.

Other names: EBUS: Olympus Keymed BF-UC260F-OL8

Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy

Procedure

Investigations will be determined by the multi-disciplinary team responsible for the patient

Primary outcomes

  1. Time from first outpatient appointment to decision to treat

    Time frame: 1 - 3 months

Secondary outcomes

  1. The healthcare costs for diagnosing and staging lung cancer

    Time frame: End of study

  2. The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer

    Time frame: 1 - 3 months

  3. The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan

    Time frame: 1 - 3 months

  4. The time from first outpatient appointment to treatment

    Time frame: 1 - 3 months

  5. The number of futile thoracotomies

    Time frame: 1 - 3 years

Sponsors and collaborators

Lead sponsor

University College London Hospitals

Other

Collaborators

  • Barnet and Chase Farm Hospitals NHS Trust
  • North Middlesex University Hospital
  • The Whittington Hospital NHS Trust

Registry information

Official study title

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

Acronym: BOOST

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Apr 4, 2008
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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