NCT00126958

Cost-Effectiveness in Bladder Cancer

Cost-Effectiveness of Follow-up of Patients With Superficial Bladder Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (planned)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	urinary analysis

Timeline

• Start date: 2002-07-01
• Completion: 2005-07-01
• First posted: 2005-08-05
• Last updated: 2009-02-19