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Cost-Effectiveness in Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00126958
Recruitment Status : Unknown
Verified August 2005 by Erasmus Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : August 5, 2005
Last Update Posted : February 19, 2009
Sponsor:
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, Roterdam, Netherlands
Albert Schweitzer Hospital
Ikazia Hospital, Rotterdam
Leiden University Medical Center
Information provided by:
Erasmus Medical Center

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 Phase 4

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 Type : Observational
Estimated Enrollment : 500 participants
Time Perspective: Prospective
Official Title: Cost-Effectiveness of Follow-up of Patients With Superficial Bladder Cancer
Study Start Date : July 2002
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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

ClinicalTrials.gov Identifier: NCT00126958     History of Changes
Other Study ID Numbers: *ZON-MW 945-02-046*
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: August 2005

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