Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: computed tomography; Other: laboratory biomarker analysis; Other: cytology specimen collection procedure; Genetic: loss of heterozygosity analysis; Genetic: microsatellite instability analysis; Genetic: microarray analysis; 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 Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Edmond Odette Cancer Centre at Sunnybrook
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
  • California
    • Stanford, California, United States, 94305-5824
      • Stanford Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
  • Maryland
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0942
      • University of Michigan Comprehensive Cancer Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Grand Strand Urology, LLP
  • Texas
    • Houston, Texas, United States, 77030-4009
      • M. D. Anderson Cancer Center at University of Texas
    • Houston, Texas, United States, 77030
      • Dan L. Duncan Cancer Center at Baylor College of Medicine
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mark P. Schoenberg, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: November 5, 2004
• First Submitted That Met QC Criteria: November 5, 2004
• First Posted (Estimate): November 8, 2004

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: bladder cancer; transitional cell carcinoma of the bladder; stage 0 bladder cancer; stage I bladder cancer
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: J0382; P30CA006973 (U.S. NIH Grant/Contract); U01CA084968 (U.S. NIH Grant/Contract); 03-12-30-05 (Other Identifier: JHM IRB); CDR0000401496 (Other Identifier: other)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No