CClinicalTrials.gg
Status unknownNCT00126958Updated Feb 19, 2009

Cost-Effectiveness in Bladder Cancer

An observational study in Bladder Cancer, sponsored by Erasmus Medical Center. Status unknown. Per ClinicalTrials.gov, last updated 2009-02-19.

Sponsored by Erasmus Medical Center · Observational

The sponsor has not verified this record recently (last verified Aug 2005), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
500
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bladder Cancer

Keywords

  • superficial urothelial cell carcinoma
  • urinary analysis
  • Loss of heterozygosity
  • FGFR3 mutation
  • follow-up
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In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 500 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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
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Study design

Time perspective
Prospective
Enrollment
500 participants

Interventions

  • Procedureurinary analysis
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00126958
Lead sponsor
Erasmus Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Reinier de Graaf Groep, Sint Franciscus Gasthuis, Vlietland Ziekenhuis, Medisch Centrum Rijnmond-Zuid, Netherlands, Havenziekenhuis, Albert Schweitzer Hospital, Netherlands, Ikazia Hospital, Rotterdam, Leiden University Medical Center
First posted
Aug 5, 2005
Start date
Jul 2002
Completion
Jul 2005
Last update
Feb 19, 2009

Study contacts

Th. van der Kwast, Prof PhD MD
principal investigator · Erasmus MC, JNI
E.C. Zwarthoff, Ph.D
principal investigator · Erasmus MC, JNI
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.

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