Cost-Effectiveness in Bladder Cancer

Sponsor

Erasmus Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00126958

Collaborator

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

500

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Procedure: urinary analysis

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.

Study Design

Study Type:

Observational

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2002

Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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