A comparison of autofluorescence bronchoscopy and videobronchoscopy for the detection of precancerous lesions in patients with suspected lung cancer

ISRCTN	ISRCTN13176647
DOI	https://doi.org/10.1186/ISRCTN13176647
Secondary identifying numbers	N0201171075

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Pallav Shah
Scientific

Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom

Phone	+44 020 7351 8021
Email	pallav.shah@ic.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	The objective of the current study is to assess the accuracy of and correlation between the fluorescence bronchoscopy findings and the pathological findings in the patients with suspected lung cancer in comparison to videobronchoscopy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Lung
Intervention	The patient will first have a videobronchoscopy and any changes classified as normal, inflammatory changes, or suspicious. Images will be systematically captured and stored of the full endobronchial tree. The examination will then be repeated in the fluorescence mode and green fluorescence classified as normal the bluish area classified as inflammation and the magenta as suspicious. Biopsy samples will be obtained from all areas of inflammation and two areas of normal appearance. The site of biopsy will be documented but the pathologists will remind blinded to the bronchoscopy findings.
Intervention type	Other
Primary outcome measure	We therefore plan to study 100 patients and will calculate the relative sensitivity, specificity and accuracy of videobronchoscopy compared to that of fluorescence bronchoscopy.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2004
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	50 patients in year 1 and 50 patients in year 2. Total 100.
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2006

Royal Brompton & Harefield NHS Trust

London
SW3 6NP
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Royal Brompton and Harefield NHS Trust (UK)

No information available

No External Funding. NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2010		Yes	No