Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00095589
First received: November 5, 2004
Last updated: February 26, 2009
Last verified: February 2009
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 500
Study Start Date: August 2004
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095589

Locations
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
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
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
Investigators
Principal Investigator: Mark P. Schoenberg, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00095589     History of Changes
Obsolete Identifiers: NCT00185627
Other Study ID Numbers: CDR0000401496, JHOC-03123005, JHOC-J0382
Study First Received: November 5, 2004
Last Updated: February 26, 2009
Health Authority: United States: Federal Government

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
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014