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Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Completed
CT.gov ID
NCT00095589
Collaborator
National Cancer Institute (NCI) (NIH)
125
Enrollment
13
Locations
58
Duration (Months)
9.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

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 Design

Study Type:
Observational
Actual Enrollment :
125 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study
Study Start Date :
Aug 1, 2004
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    DISEASE CHARACTERISTICS:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham Alabama United States 35294
    2 Stanford Cancer Center Stanford California United States 94305-5824
    3 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    4 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    5 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0942
    6 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri United States 63110
    7 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    8 James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York United States 14642
    9 Grand Strand Urology, LLP Myrtle Beach South Carolina United States 29572
    10 M. D. Anderson Cancer Center at University of Texas Houston Texas United States 77030-4009
    11 Dan L. Duncan Cancer Center at Baylor College of Medicine Houston Texas United States 77030
    12 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229-3900
    13 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)

    Investigators

    • Principal Investigator: Mark P. Schoenberg, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    ClinicalTrials.gov Identifier:
    NCT00095589
    Other Study ID Numbers:
    • J0382
    • U01CA084968
    • P30CA006973
    • 03-12-30-05
    • CDR0000401496
    • NCT00185627
    First Posted:
    Nov 8, 2004
    Last Update Posted:
    Feb 8, 2019
    Last Verified:
    Feb 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    bladder cancer
    stage 0 bladder cancer
    stage I bladder cancer
    transitional cell carcinoma of the bladder
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Feb 8, 2019