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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University College London Hospitals.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
North Middlesex University Hospital
Barnet and Chase Farm Hospitals NHS Trust
The Whittington Hospital NHS Trust
Information provided by (Responsible Party):
Sam Janes, University College London Hospitals
ClinicalTrials.gov Identifier:
NCT00652769
First received: April 1, 2008
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Bronchogenic Carcinoma
Procedure: Endobronchial or Endoscopic Ultrasound
Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Trial of Endobronchial or Endoscopic Ultrasound as a First Test in the Diagnosis and Staging of Lung Cancer

Resource links provided by NLM:


Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • Time from first outpatient appointment to decision to treat [ Time Frame: 1 - 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The healthcare costs for diagnosing and staging lung cancer [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer [ Time Frame: 1 - 3 months ] [ Designated as safety issue: No ]
  • The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan [ Time Frame: 1 - 3 months ] [ Designated as safety issue: No ]
  • The time from first outpatient appointment to treatment [ Time Frame: 1 - 3 months ] [ Designated as safety issue: No ]
  • The number of futile thoracotomies [ Time Frame: 1 - 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: March 2008
Estimated Study Completion Date: July 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: EBUS: Olympus Keymed BF-UC260F-OL8

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652769

Locations
United Kingdom
University College London Hospital NHS Trust
London, United Kingdom, WC1E 6AU
North Middlesex University Hospital
London, United Kingdom, N18 1QX
Barnet General Hospital
London, United Kingdom, EN5 3DJ
Whittington Hospital NHS Trust
London, United Kingdom, N19 5NF
Sponsors and Collaborators
University College London Hospitals
North Middlesex University Hospital
Barnet and Chase Farm Hospitals NHS Trust
The Whittington Hospital NHS Trust
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
  More Information

Publications:
Responsible Party: Sam Janes, Reader in Respiratory Medicine, University College London Hospitals
ClinicalTrials.gov Identifier: NCT00652769     History of Changes
Other Study ID Numbers: 07/0156
Study First Received: April 1, 2008
Last Updated: October 17, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University College London Hospitals:
Lung
Cancer
Staging
Endobronchial
Ultrasound
Endoscopic

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Bronchogenic
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014