Condition category
Cancer
Date applied
25/07/2005
Date assigned
02/09/2005
Last edited
19/11/2015
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

Mr Timothy O'Brien

ORCID ID

Contact details

Dept. Urology
1st Floor Thomas Guy House
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
+44 (0)207 1886796
tim.obrien@gstt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/QO603/42

Study information

Scientific title

A randomised study of 'bluelight' hexyl aminolevulinic acid (HAL) photodynamic assisted resection of bladder tumours versus conventional 'whitelight' transurethral resection of newly diagnosed bladder tumours comparing rates of tumour recurrence over one year - a Phase IV trial

Acronym

Study hypothesis

The aim is to determine if photodynamic assisted resection can reduce the recurrence rate of tumour at one year when compared with the control group. The primary endpoint is the diagnosis of recurrent tumour at 3 months or 12 months on check cystoscopy.

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

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

Bladder cancer

Intervention

Intervention: Pre-operative intravesical instillation of solution of hexylaminolevulinic acid (HAL) - photodynamic 'bluelight' assisted resection of bladder tumours
Control: Conventional 'whitelight' transurethral resection

Intervention type

Drug

Phase

Phase IV

Drug names

Hexyl aminolevulinic acid (HAL)

Primary outcome measures

Recurrence rates of bladder tumour at 3 months and 12 months post surgery

Secondary outcome measures

Analysis of histology

Overall trial start date

01/02/2005

Overall trial end date

01/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. New diagnosis of bladder tumour - the study is designed to reduce recurrence rates in newly diagnosed cases of bladder tumours
2. Superficial disease - the study will address the recurrence rates in superficial bladder cancer
3. No history of previous bladder surgery - previous surgical procedures to the bladder may cause artifactual changes when using 'blue light' cystoscopy
4. Life expectancy of at least 1-year - study duration will be for 1-year

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 (100 in each group)

Participant exclusion criteria

1. Previous bladder tumour or coexisting/previous upper tract disease - the study is designed to reduce recurrence rates in newly diagnosed cases of bladder tumours
2. Muscle invasive disease - the study will address the recurrence rates in superficial bladder cancer
3. Previous bladder surgery -previous surgical procedures to the bladder may cause artifactual changes when using 'blue light' cystoscopy

Recruitment start date

01/02/2005

Recruitment end date

01/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's Hospital
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Guy's Hospital - Research and Development Department (UK)

Sponsor details

Ground Floor
West Wing Counting House
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Guy's and St Thomas' Charity (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24053153

Publication citations

Additional files

Editorial Notes