Overview

This trial is active, not recruiting.

Condition bladder cancer
Treatment urinary analysis
Phase phase 4
Sponsor Erasmus Medical Center
Collaborator ZonMw: The Netherlands Organisation for Health Research and Development
Start date July 2002
End date July 2005
Trial size 500 participants
Trial identifier NCT00126958, *ZON-MW 945-02-046*

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Cost-Effectiveness of Follow-up of Patients With Superficial Bladder Cancer
Principal investigator Th. van der Kwast, Prof PhD MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Erasmus Medical Center.