Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
NCT ID: NCT00095589
Last Updated: 2019-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
125 participants
OBSERVATIONAL
2004-08-31
2009-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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loss of heterozygosity analysis
microarray analysis
microsatellite instability analysis
cytology specimen collection procedure
laboratory biomarker analysis
computed tomography
cystoscopy
Eligibility Criteria
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Inclusion Criteria
* Group 1 (healthy volunteers):
* No prior or concurrent urologic disease or devices
* No genitourinary (GU) complaints, including urgency or frequency of urination
* Normal urinalysis and urine cytology
* Never smoked cigarettes regularly (i.e., ≥ 1 cigarette/day for ≥ 1 year)
* No suspected exposure to environmental bladder carcinogens for \> 1 year, including, but not limited to, the following occupations or exposures:
* Aluminum industry
* Aromatic amines
* Coal gasification
* Coal tars and pitches
* Coke plant
* Dye industry
* Leather industry
* Machinist
* Painter
* Rubber industry
* Truck, bus, or taxi drivers
* Group 2 (participants with condition(s) that lead to false-positive urinary bladder cancer screening studies):
* GU complaints requiring cystoscopy
* No current GU malignancy
* At least 1 of the following conditions:
* Benign prostatic hypertrophy (International Prostate Symptom Score \> 12)
* Foreign bodies (stones, stents, or catheters)
* Hematuria (gross or microscopic)
* GU infection (e.g., prostatitis, urinary tract infection, pyelonephritis, urethritis) within the past 3 months and completed treatment
* No sign of infection at the time of study participation
* Group 3 (superficial bladder cancer patients):
* Histologically confirmed superficial bladder urothelial malignancy
* Primary or recurrent disease
* No nontransitional cell carcinoma of the bladder, upper tract tumors, muscle-invasive tumors, or superficial disease for which local therapy is not appropriate
PATIENT CHARACTERISTICS:
Age
* Over 40
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* See Disease Characteristics
Other
* No prior cancer except nonmelanoma dermatologic malignancy
* Prior bladder cancer allowed for group 3 patients
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
* Prior intravesical therapy for bladder cancer allowed for group 3 patients
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
Surgery
* Not specified
40 Years
120 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Mark P. Schoenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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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
St 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
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada
Countries
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Other Identifiers
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03-12-30-05
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000401496
Identifier Type: OTHER
Identifier Source: secondary_id
J0382
Identifier Type: -
Identifier Source: org_study_id
NCT00185627
Identifier Type: -
Identifier Source: nct_alias
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