Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

Completed

• Conditions: Bladder Cancer

• Registration Number: NCT00095589
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

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 (e.g., 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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-11-05
• Study First Submitted QC: 2004-11-05
• Study First Posted: 2004-11-08
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (13)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis; 🇺🇸 Saint Louis, Missouri, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Grand Strand Urology, LLP; 🇺🇸 Myrtle Beach, South Carolina, United States

M. D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States

Scroll for more (3 remaining)