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

October 31, 2017 updated by: Sam Janes, University College London Hospitals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, N18 1QX
        • North Middlesex University Hospital
      • London, United Kingdom, N19 5NF
        • Whittington Hospital NHS Trust
      • London, United Kingdom, EN5 3DJ
        • Barnet General Hospital
      • London, United Kingdom, WC1E 6AU
        • University College London Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy
Investigations will be determined by the multi-disciplinary team responsible for the patient
Experimental: 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.
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.
Other Names:
  • EBUS: Olympus Keymed BF-UC260F-OL8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from first outpatient appointment to decision to treat
Time Frame: 1 - 3 months
1 - 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College London Hospitals

Collaborators

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

Investigators

  • Principal Investigator: Stephen Spiro, MD, Univeristy College London NHS Trust
  • Study Chair: Sam Janes, MD PhD, University College, London
  • Study Director: Neal Navani, MD, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/0156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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