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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24053153