This randomized clinical multicentre trial aims to evaluate the efficacy of microsatellite analysis on voided urine to detect tumour recurrences in the follow-up of patients with superficial urothelialcell carcinoma (UCC). Further, this study aims to identify subgroups of patients with a low risk of tumour recurrence using clinico-pathologic tumour characteristics in combination with a genetic marker (FGFR3 gene), such that the frequency of follow-up contact can be reduced. The overall objective is to reduce the frequency of cystoscopy during follow-up in patients with superficial UCC, leading to an improvement in quality of life at equal or lower costs. This study evaluates the cost-effectiveness of follow-up in bladder cancer.

Condition	Intervention	Phase
Bladder Cancer	Procedure: urinary analysis	Phase IV

Further Study Details: 

Expected Total Enrollment:  500

The randomized clinical study consists of two intervention arms. The control arm consists of a conventional follow-up based on regular monitoring for urinary bladder UCC recurrences by cystoscopy. In the test arm a proportion of the cystoscopies is replaced by microsatellite analysis on voided urine. Both arms will be stratified for clinical and pathological tumour parameters as well as for the mutation status of the prognostic FGFR3 gene mutation.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• All patients with resectable pT1 or pTa, grade G1-G2 transitional cell carcinoma of the bladder which is biopsy proven

Exclusion Criteria:

• Patients who present or presented with a transitional cell carcinoma of the bladder, stage pT2 or more invasive, or carcinoma in situ (CIS) and/or G3 diagnosed in history

Study chairs or principal investigators

Th. van der Kwast, Prof PhD MD,  Principal Investigator,  Erasmus MC, JNI   
E.C. Zwarthoff, Ph.D,  Principal Investigator,  Erasmus MC, JNI   

Study ID Numbers:  *ZON-MW 945-02-046*
Last Updated:  August 19, 2005
Record first received:  August 4, 2005
ClinicalTrials.gov Identifier:  NCT00126958
Health Authority: Netherlands: Independent Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-23