Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095589
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2004-11-05
Brief Title:
Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Detection of Bladder Cancer by Microsatellite Analysis MSA of Urinary Sediment Multi-Institutional Study
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
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:
RATIONALE New diagnostic procedures such as microsatellite analysis of sediment in the urine may improve the ability to detect bladder cancer without invasive procedures
PURPOSE Diagnostic trial to study the effectiveness of microsatellite analysis of sediment in the urine in detecting bladder cancer in healthy participants participants who have genitourinary conditions requiring cystoscopy and patients who have bladder cancer
PURPOSE Diagnostic trial to study the effectiveness of microsatellite analysis of sediment in the urine in detecting bladder cancer in healthy participants participants who have genitourinary conditions requiring cystoscopy and patients who have bladder cancer
Detailed Description:
OBJECTIVES
Primary
Compare the sensitivity and specificity of microsatellite analysis MSA of urine sediment with cystoscopy and urine cytology for detecting bladder cancer in participants undergoing cystoscopy
Secondary
Determine the temporal performance characteristics of MSA in urine sediment from these participants
Determine which of the 15 individual markers or combination of markers that make up the MSA test are most predictive of the presence of bladder cancer in these participants
OUTLINE This is a single-blind multicenter cohort study
Urine and blood specimens are collected from all participants at baseline Urine specimens are examined using microsatellite analysis urine cytology and urinalysis Patients in groups 2 and 3 also undergo cystoscopy at baseline
Patients in group 3 undergo cystoscopy upper tract imaging eg abdominal CT scan microsatellite analysis urine cytology and urinalysis every 3 months for 2 years in the absence of progressive disease
Microsatellite analysis which identifies loss of heterozygosity using polymerase chain reaction technique is conducted for 15 markers D4S243 D21S1245 FGA D17S695 D16S476 D9S171 IFN-A D20S48 D13S802 D17S654 D16S310 THO1 D9S162 D9S747 and MBP
PROJECTED ACCRUAL A total of 500 participants 100 each for groups 1 and 2 and 300 for group 3 will be accrued for this study
Primary
Compare the sensitivity and specificity of microsatellite analysis MSA of urine sediment with cystoscopy and urine cytology for detecting bladder cancer in participants undergoing cystoscopy
Secondary
Determine the temporal performance characteristics of MSA in urine sediment from these participants
Determine which of the 15 individual markers or combination of markers that make up the MSA test are most predictive of the presence of bladder cancer in these participants
OUTLINE This is a single-blind multicenter cohort study
Urine and blood specimens are collected from all participants at baseline Urine specimens are examined using microsatellite analysis urine cytology and urinalysis Patients in groups 2 and 3 also undergo cystoscopy at baseline
Patients in group 3 undergo cystoscopy upper tract imaging eg abdominal CT scan microsatellite analysis urine cytology and urinalysis every 3 months for 2 years in the absence of progressive disease
Microsatellite analysis which identifies loss of heterozygosity using polymerase chain reaction technique is conducted for 15 markers D4S243 D21S1245 FGA D17S695 D16S476 D9S171 IFN-A D20S48 D13S802 D17S654 D16S310 THO1 D9S162 D9S747 and MBP
PROJECTED ACCRUAL A total of 500 participants 100 each for groups 1 and 2 and 300 for group 3 will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000401496 | OTHER | other | httpsreporternihgovquickSearchP30CA006973 |
| U01CA084968 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| 03-12-30-05 | OTHER | None | None |