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

Primary Purpose

Bronchogenic Carcinoma

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Endobronchial or Endoscopic Ultrasound
Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy
Sponsored by
University College London Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchogenic Carcinoma focused on measuring Lung, Cancer, Staging, Endobronchial, Ultrasound, Endoscopic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnet General Hospital
  • North Middlesex University Hospital
  • Whittington Hospital NHS Trust
  • University College London Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

B

A

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time from first outpatient appointment to decision to treat

Secondary Outcome Measures

The healthcare costs for diagnosing and staging lung cancer
The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer
The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan
The time from first outpatient appointment to treatment
The number of futile thoracotomies

Full Information

First Posted
April 1, 2008
Last Updated
October 31, 2017
Sponsor
University College London Hospitals
Collaborators
North Middlesex University Hospital, Barnet and Chase Farm Hospitals NHS Trust, The Whittington Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00652769
Brief Title
A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)
Acronym
BOOST
Official Title
A Randomized Controlled Trial of Endobronchial or Endoscopic Ultrasound as a First Test in the Diagnosis and Staging of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College London Hospitals
Collaborators
North Middlesex University Hospital, Barnet and Chase Farm Hospitals NHS Trust, The Whittington Hospital NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchogenic Carcinoma
Keywords
Lung, Cancer, Staging, Endobronchial, Ultrasound, Endoscopic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Active Comparator
Arm Description
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.
Arm Title
A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endobronchial or Endoscopic Ultrasound
Other Intervention Name(s)
EBUS: Olympus Keymed BF-UC260F-OL8
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy
Intervention Description
Investigations will be determined by the multi-disciplinary team responsible for the patient
Primary Outcome Measure Information:
Title
Time from first outpatient appointment to decision to treat
Time Frame
1 - 3 months
Secondary Outcome Measure Information:
Title
The healthcare costs for diagnosing and staging lung cancer
Time Frame
End of study
Title
The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer
Time Frame
1 - 3 months
Title
The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan
Time Frame
1 - 3 months
Title
The time from first outpatient appointment to treatment
Time Frame
1 - 3 months
Title
The number of futile thoracotomies
Time Frame
1 - 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Spiro, MD
Organizational Affiliation
Univeristy College London NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sam Janes, MD PhD
Organizational Affiliation
University College, London
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Neal Navani, MD
Organizational Affiliation
University College, London
Official's Role
Study Director
Facility Information:
Facility Name
Barnet General Hospital
City
London
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom
Facility Name
North Middlesex University Hospital
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Whittington Hospital NHS Trust
City
London
ZIP/Postal Code
N19 5NF
Country
United Kingdom
Facility Name
University College London Hospital NHS Trust
City
London
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
11809983
Citation
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. doi: 10.1136/thorax.57.1.11.
Results Reference
background
PubMed Identifier
17873169
Citation
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. doi: 10.1378/chest.07-1362.
Results Reference
background
PubMed Identifier
17873168
Citation
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. doi: 10.1378/chest.07-1360.
Results Reference
background
PubMed Identifier
17448671
Citation
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. doi: 10.1016/j.ejcts.2007.01.075. Epub 2007 Apr 19.
Results Reference
background
PubMed Identifier
17277288
Citation
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. doi: 10.1164/rccm.200609-1390ED. No abstract available.
Results Reference
background
PubMed Identifier
19390554
Citation
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. doi: 10.1038/nrclinonc.2009.39.
Results Reference
background
PubMed Identifier
25660225
Citation
Navani N, Nankivell M, Lawrence DR, Lock S, Makker H, Baldwin DR, Stephens RJ, Parmar MK, Spiro SG, Morris S, Janes SM; Lung-BOOST trial investigators. Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial. Lancet Respir Med. 2015 Apr;3(4):282-9. doi: 10.1016/S2213-2600(15)00029-6. Epub 2015 Feb 4.
Results Reference
derived

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

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