Condition category
Cancer
Date applied
27/03/2008
Date assigned
23/05/2008
Last edited
20/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Sam Janes

ORCID ID

Contact details

Centre for Respiratory Research
University College London
Rayne Building
5 University Street
London
WC1W 6JF
United Kingdom
s.janes@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of endobronchial ultrasound or endoscopic ultrasound as a first test in the diagnosis and staging of lung cancer

Acronym

BOOST

Study hypothesis

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

Charing Cross Research Ethics Committee (REC) on behalf of the National Research Ethics Service REC on 08/02/2008 (ref: 07/H0711/127)

Study design

Open-label multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

07/04/2008

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

168

Participant 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

Recruitment start date

07/04/2008

Recruitment end date

01/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Respiratory Research
London
WC1W 6JF
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

235 Euston Road
London
NW1 2BU
United Kingdom

Sponsor type

Government

Website

http://www.uclh.nhs.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes