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ISRCTN
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ISRCTN88118697
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DOI
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10.1186/ISRCTN88118697
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised trial of intravesical irrigation in superficial bladder cancer followed by treatment with epodyl or mitomycin C at the time of first recurrence
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Scientific title
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Acronym
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N/A
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Serial number at source
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BS04
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Study hypothesis
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1. To detect the reduction, if any, of recurrence following irrigation of the bladder with glycine following complete resection of newly diagnosed bladder cancer
2. To compare the effect of Mitomycin-C against Epodyl in patients who develop recurrent superficial tumour following the initial transurethral resection in preventing further recurrence
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Bladder cancer
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Participants - inclusion criteria
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1. Newly diagnosed superficial bladder cancer suitable for complete endoscopic resection
2. Transitional cell carcinoma limited to the bladder, no evidence of carcinoma in the upper tracts
3. World Health Organisation (WHO) performance status 0-2
4. Expected survival at least 3 years
5. White count greater than 3 x 10^9/L and platelets greater than 100 x 10^9/L
6. No untreated urinary tract infection
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/07/1987
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Anticipated end date
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01/12/1995
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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1000
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Interventions
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Epodyl or mitomycin C
Follow-up: 3 monthly for 1st year, 6 monthly for 2nd year, annually thereafter.
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Primary outcome measure(s)
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Recurrence free survival
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Contact name
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Dr
Danielle
Andrews
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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13/03/2001
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Last edited
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06/06/2012
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Date ISRCTN assigned
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13/03/2001
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