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
| ISRCTN | ISRCTN14275387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14275387 |
| Secondary identifying numbers | 04/QO603/42 |
- Submission date
- 25/07/2005
- Registration date
- 02/09/2005
- Last edited
- 19/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Timothy O'Brien
Scientific
Scientific
Dept. Urology
1st Floor Thomas Guy House
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
| Phone | +44 (0)207 1886796 |
|---|---|
| tim.obrien@gstt.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2005 |
| Completion date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 (100 in each group) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 01/02/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Guy's Hospital - Research and Development Department (UK)
Hospital/treatment centre
Hospital/treatment centre
Ground Floor
West Wing Counting House
Guy's Hospital
St Thomas' Street
London
SE1 9RT
England
United Kingdom
"ROR" |
https://ror.org/04r33pf22 |
|---|
Funders
Funder type
Charity
Guy's and St Thomas' Charity (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
- Location
- United Kingdom
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2013 | Yes | No |
