Audit/research project for follow-up cystoscopy superficial bladder cancer

ISRCTN	ISRCTN24647129
DOI	https://doi.org/10.1186/ISRCTN24647129
Secondary identifying numbers	SUPBLACAN

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 24/10/2019

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

Mr R Hall
Scientific

Freeman Hospital
Newcastle
NE7 7DN
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Audit/research project for follow-up cystoscopy superficial bladder cancer
Study objectives	1. To conduct an audit of a new programme of cystoscopic follow-up for patients with Ta. T1 bladder carcinoma. 2. To conduct a randomised comparison of: 2.1. Mitocytin-C versus epirubicin as single intravesical instillations at the time of diagnosis to evaluate relative efficacy in prevention of recurrent bladder cancer 2.2. A single instillation of intravesical chemotherapy (MMC or Epi) versus five instillations (to be given at the time of each follow-up cystoscopy for 1 year) to determine the relative efficacy in reducing tumour recurrence in medium risk Ta.T1 bladder cancer.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer (neoplasms): Bladder (superficial)
Intervention	Not provided at time of registration
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Mitocytin-C versus Epirubicin
Primary outcome measure	1.1 Number of unplanned incidents (return with symptoms, need for unscheduled cystoscopies or tumour resections). 1.2 Tumour recurrence rate and number of patients progressing to muscle invasion at 2 years. iii. Inter-hospital variation of type of cystoscopy, anaesthetic, out-patient, day case, in-patient mix and cost of same. 2. Recurrence rate and progression to muscle invasion at 2 years.
Secondary outcome measures	Not provided at time of registration
Overall study start date	16/05/1994
Completion date	15/05/1997

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	16/05/1994
Date of final enrolment	15/05/1997

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Freeman Hospital

Newcastle
NE7 7DN
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

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

Editorial Notes

24/10/2019: No publications found. All search options exhausted.