Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
20/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pallav Shah

ORCID ID

Contact details

Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom
+44 020 7351 8021
pallav.shah@ic.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0201171075

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

50 patients in year 1 and 50 patients in year 2. Total 100.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Royal Brompton and Harefield NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

No External Funding. NHS R&D Support Funding

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20436177

Publication citations

  1. Results

    Cetti EJ, Nicholson AG, Singh S, Wells AU, Shah PL, An evaluation of a videobronchoscopy-based autofluorescence system in lung cancer., Eur. Respir. J., 2010, 35, 5, 1185-1187, doi: 10.1183/09031936.00148809.

Additional files

Editorial Notes