Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00095589
Recruitment Status : Unknown
Verified February 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : November 8, 2004
Last Update Posted : February 27, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Genetic: loss of heterozygosity analysis Genetic: microarray analysis Genetic: microsatellite instability analysis Other: cytology specimen collection procedure Other: laboratory biomarker analysis Procedure: computed tomography Procedure: cystoscopy Not Applicable

Detailed Description:



  • 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.


  • 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Masking: Single
Primary Purpose: Diagnostic
Official Title: Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study
Study Start Date : August 2004
Estimated Primary Completion Date : June 2009

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:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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



  • Over 40

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • See Disease Characteristics


  • No prior cancer except nonmelanoma dermatologic malignancy

    • Prior bladder cancer allowed for group 3 patients


Biologic therapy

  • Not specified


  • No prior chemotherapy

    • Prior intravesical therapy for bladder cancer allowed for group 3 patients

Endocrine therapy

  • Not specified


  • No prior radiotherapy


  • Not specified

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 identifier (NCT number): NCT00095589

United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5824
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, South Carolina
Grand Strand Urology, LLP
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Canada, Ontario
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Principal Investigator: Mark P. Schoenberg, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00095589     History of Changes
Obsolete Identifiers: NCT00185627
Other Study ID Numbers: CDR0000401496
First Posted: November 8, 2004    Key Record Dates
Last Update Posted: February 27, 2009
Last Verified: February 2009

Keywords provided by National Cancer Institute (NCI):
bladder cancer
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases