Cost-Effectiveness in Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00126958
• Other study ID #: *ZON-MW 945-02-046*
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 4, 2005
• Last updated: February 18, 2009
• Start date: July 2002
• Est. completion date: July 2005

Study information

• Verified date: August 2005
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• urinary analysis

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Erasmus Medical Center	Albert Schweitzer Hospital, Havenziekenhuis, Roterdam, Netherlands, Ikazia Hospital, Rotterdam, Leiden University Medical Center, Medisch Centrum Rijnmond-Zuid, Netherlands, Reinier de Graaf Groep, Sint Franciscus Gasthuis, Vlietland Ziekenhuis, ZonMw: The Netherlands Organisation for Health Research and Development