Condition category
Cancer
Date applied
09/09/2011
Date assigned
20/01/2012
Last edited
20/01/2012
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 Gregers G Hermann

ORCID ID

Contact details

Department of Urology
Frederiksberg Hospital
Ndr Fasanvej 57
Copenhagen
DK-2000
Denmark
gregershermann@frh.regionh.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UOF no 3

Study information

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).

Acronym

UOF3

Study hypothesis

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

Not provided at time of registration

Study design

Single center study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Histological diagnosis from evaluation of bladder biopsy

Secondary outcome measures

Quality of life and pain in relation to test procedures

Overall trial start date

01/12/2011

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who have had 6 weekly BCG bladder instillations as treatment of primary or secondary carcinoma in situ of the bladder.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

Patients who do not understand Danish or who the investigators do not find able to fulfil the study

Recruitment start date

01/12/2011

Recruitment end date

30/04/2013

Locations

Countries of recruitment

Denmark

Trial participating centre

Department of Urology
Copenhagen
DK-2000
Denmark

Sponsor information

Organisation

Frederiksberg Hospital (Denmark)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.frederiksberghospital.dk/

Funders

Funder type

Hospital/treatment centre

Funder name

Frederiksberg Hospital, Copenhagen University (Denmark)

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

Publication citations

Additional files

Editorial Notes