Evaluation of treatment of local bladder cancer with Bacille Calmette-Guérin (BCG). Is treatment follow up in the outpatient department just as good as follow up in the operating theatre?
| ISRCTN | ISRCTN48222814 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48222814 |
| Secondary identifying numbers | UOF no 3 |
- Submission date
- 09/09/2011
- Registration date
- 20/01/2012
- Last edited
- 20/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gregers G Hermann
Scientific
Scientific
Department of Urology
Frederiksberg Hospital
Ndr Fasanvej 57
Copenhagen
DK-2000
Denmark
| gregershermann@frh.regionh.dk |
Study information
| Study design | Single center study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Detection rate of carcinoma in situ (CIS) after intravesical Bacille Calmette-Guérin (BCG) in fluorescence guided flexible cystoscopy in the outpatient department (OPD) compared to fluorescence guided cystoscopy in rigid cystoscopes in the operating theatre (OT). |
| Study acronym | UOF3 |
| Study objectives | Fluorescence guided cystoscopy and biopsy performed in the OPD is just as good as fluorescence guided cystoscopy and biopsy in rigid scopes in the operating theatre to evaluate the efficacy of intra vesical BCG therapy of carcinoma in situ. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer of the urinary bladder - carcinoma of the bladder - CIS |
| Intervention | Fluorescence guided cystoscopy and biopsy in rigid scopes in the operating theatre and in flexible cystoscopes in the outpatient department |
| Intervention type | Other |
| Primary outcome measure | Histological diagnosis from evaluation of bladder biopsy |
| Secondary outcome measures | Quality of life and pain in relation to test procedures |
| Overall study start date | 01/12/2011 |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | Patients who have had 6 weekly BCG bladder instillations as treatment of primary or secondary carcinoma in situ of the bladder. |
| Key exclusion criteria | Patients who do not understand Danish or who the investigators do not find able to fulfil the study |
| Date of first enrolment | 01/12/2011 |
| Date of final enrolment | 30/04/2013 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Department of Urology
Copenhagen
DK-2000
Denmark
DK-2000
Denmark
Sponsor information
Frederiksberg Hospital (Denmark)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Gregers G Hermann
Department of Urology
Frederiksberg Hospital
University of Copenhagen
Ndr. Fasanvej 57
Frederiksberg
Copenhagen
DK-2000
Denmark
| gregers.hermann@frh.regionh.dk | |
| Website | http://www.frederiksberghospital.dk/ |
"ROR" |
https://ror.org/00d264c35 |
Funders
Funder type
Hospital/treatment centre
Frederiksberg Hospital, Copenhagen University (Denmark)
No information available
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 |
