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Cost-Effectiveness in Bladder Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Erasmus Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Reinier de Graaf Groep
Sint Franciscus Gasthuis
Vlietland Ziekenhuis, Schiedam, Netherlands
Medisch Centrum Rijnmond-Zuid, Netherlands
Havenziekenhuis, Roterdam, Netherlands
Albert Schweitzer Hospital
Ikazia Hospital, Rotterdam
Leiden University Medical Center
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00126958
First received: August 4, 2005
Last updated: February 18, 2009
Last verified: August 2005
History of Changes
  Purpose

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 Intervention Phase
Bladder Cancer
 Procedure: urinary analysis
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cost-Effectiveness of Follow-up of Patients With Superficial Bladder Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Estimated Enrollment: 500
Study Start Date: July 2002
Estimated Study Completion Date: July 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126958

Sponsors and Collaborators
Erasmus Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Reinier de Graaf Groep
Sint Franciscus Gasthuis
Vlietland Ziekenhuis, Schiedam, Netherlands
Medisch Centrum Rijnmond-Zuid, Netherlands
Havenziekenhuis, Roterdam, Netherlands
Albert Schweitzer Hospital
Ikazia Hospital, Rotterdam
Leiden University Medical Center
Investigators
Principal Investigator: Th. van der Kwast, Prof PhD MD Erasmus MC, JNI
Principal Investigator: E.C. Zwarthoff, Ph.D Erasmus MC, JNI
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00126958     History of Changes
Other Study ID Numbers: *ZON-MW 945-02-046*
Study First Received: August 4, 2005
Last Updated: February 18, 2009
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Erasmus Medical Center:
superficial urothelial cell carcinoma
urinary analysis
Loss of heterozygosity
FGFR3 mutation
follow-up

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013