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Cost-Effectiveness in Bladder Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00126958
Enrollment
500
Registered
2005-08-05
Start date
2002-07-31
Completion date
2005-07-31
Last updated
2009-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

superficial urothelial cell carcinoma, urinary analysis, Loss of heterozygosity, FGFR3 mutation, follow-up

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.

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.

Interventions

PROCEDUREurinary analysis

Sponsors

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

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026