BOOST: A new pathway with BronchOscopic or Oesophageal ultrasound for lung cancer diagnosis and STaging

ISRCTN	ISRCTN49573946
DOI	https://doi.org/10.1186/ISRCTN49573946
ClinicalTrials.gov (NCT)	NCT00652769
Protocol serial number	N/A
Sponsor	University College London Hospitals NHS Foundation Trust (UK)
Funder	Investigator initiated and funded (UK)

Submission date: 27/03/2008
Registration date: 23/05/2008
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-endobronchial-ultrasound-or-endoscopic-ultrasound-to-diagnose-lung-cancer-and-see-how-far-it-has-spread

Contact information

Dr Sam Janes
Scientific

Centre for Respiratory Research
University College London
Rayne Building
5 University Street
London
WC1W 6JF
United Kingdom

Email	s.janes@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Open-label multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial of endobronchial ultrasound or endoscopic ultrasound as a first test in the diagnosis and staging of lung cancer
Study acronym	BOOST
Study objectives	EUS (endoscopic ultrasound) or EBUS (endobronchial ultrasound guided transbronchial needle aspirate) as a first test after computed tomography (CT) scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient referral to treatment decision, a reduction in the total number of positron emission tomography (PET) scans, mediastinoscopies and futile thoracotomies, fewer outpatient attendances and a reduction in NHS healthcare costs. As of 22/02/2011 the anticipated end date for this trial has been updated from 31/10/2010 to 01/10/2011.
Ethics approval(s)	Charing Cross Research Ethics Committee (REC) on behalf of the National Research Ethics Service REC on 08/02/2008 (ref: 07/H0711/127)
Health condition(s) or problem(s) studied	Lung cancer
Intervention	Control arm: bronchoscopy, CT guided lung biopsy, PET scan, mediastinoscopy Active arm: endobronchial or endoscopic ultrasound (EUS or EBUS, respectively) Follow-up is for one year for all participants.
Intervention type	Other
Primary outcome measure(s)	Time from first outpatient appointment to decision to treat. Information for the endpoints will be collected prospectively as patients go through the diagnostic and staging process and case report forms (CRFs) will be updated weekly. The information will be obtained from multi-disciplinary team meetings (MDTs), patient notes and electronic patient records.
Key secondary outcome measure(s)	1. The health care costs of diagnosing and staging lung cancer 2. The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer 3. The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan 4. The time from first outpatient appointment to treatment 5. The number of futile thoracotomies Information for the endpoints will be collected prospectively as patients go through the diagnostic and staging process and case report forms (CRFs) will be updated weekly. The information will be obtained from multi-disciplinary team meetings (MDTs), patient notes and electronic patient records.
Completion date	01/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	168
Total final enrolment	133
Key inclusion criteria	1. Aged greater than 18 years, either sex 2. Consecutive patients suspected of lung cancer on CT scan 3. Written informed consent 4. Able to tolerate fibre-optic bronchoscopy
Key exclusion criteria	1. Evidence of severe or uncontrolled systemic disease that makes it undesirable for the patient to participate in the trial 2. Any disorder making reliable informed consent impossible 3. Patient unlikely to tolerate bronchoscopy 4. Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion
Date of first enrolment	07/04/2008
Date of final enrolment	01/10/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Centre for Respiratory Research

London
WC1W 6JF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2015	10/09/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link added.
10/09/2019: ClinicalTrials.gov number, publication reference and total final enrolment number added.
15/03/2017: No publications found, verifying study status with principal investigator.