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

Sponsors and Collaborators:	University College London Hospitals North Middlesex University Hospital Barnet and Chase Farm Hospitals NHS Trust The Whittington Hospital NHS Trust
Information provided by:	University College London Hospitals
ClinicalTrials.gov Identifier:	NCT00652769

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 III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Parallel Assignment, Efficacy Study
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 Ultrasound

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:	October 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Active Comparator 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
A: Experimental 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.

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 fibre-optic bronchoscopy

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
Patient unlikely to tolerate bronchoscopy
Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion

Contacts and Locations

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

Contacts

Contact: Neal Navani, MD	44-795-160-2494	neal.navani@uclh.nhs.uk
Contact: Sam Janes, MD PhD		s.janes@ucl.ac.uk

Locations

United Kingdom
University College London Hospital NHS Trust	Recruiting
London, United Kingdom, WC1E 6AU
Contact: Neal Navani, MD 44-795-160-2494 neal.navani@uclh.nhs.uk
Contact: Sam Janes, MD PhD s.janes@ucl.ac.uk
Principal Investigator: Sam Janes, MD PhD
North Middlesex University Hospital	Recruiting
London, United Kingdom, N18 1QX
Contact: Neal Navani, MD neal.navani@uclh.nhs.uk
Contact: Himender Makker, MD himender@makker.freeserve.co.uk
Principal Investigator: Himender Makker, MD
Barnet General Hospital	Not yet recruiting
London, United Kingdom, EN5 3DJ
Contact: Neal Navani, MD neal.navani@uclh.nhs.uk
Whittington Hospital NHS Trust	Not yet recruiting
London, United Kingdom, N19 5NF
Contact: Neal Navani, MD neal.navani@uclh.nhs.uk

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.

Responsible Party:	University College London ( Dr S Janes, Senior Lecturer and Honorary Consultant )
Study ID Numbers:	07/0156
Study First Received:	April 1, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00652769 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University College London Hospitals:

Lung
Cancer
Staging

Endobronchial
Ultrasound
Endoscopic

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Esophageal Disorder
Lung Neoplasms
Lung Diseases

Esophageal Diseases
Carcinoma, Bronchogenic
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Bronchogenic
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 10, 2009