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

This study is ongoing, but not recruiting participants.

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

History of Changes

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:

MedlinePlus related topics: CT Scans Cancer Endoscopy Lung Cancer Nuclear Scans

U.S. FDA Resources

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

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:

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.

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.

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.

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.

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. No abstract available.

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. Review.

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 May 16, 2013

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