Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126958
Status:
UNKNOWN
Last Update Posted:
2009-02-19
First Post:
2005-08-04
Brief Title:
Cost-Effectiveness in Bladder Cancer
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Cost-Effectiveness of Follow-up of Patients With Superficial Bladder Cancer
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None