Clinical trial NCT00095589: Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
Official title: Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: bladder cancer
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-11-08
Enrollment: 125
Sex: ALL
Minimum age (years): 40
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
city: Myrtle Beach
country: United States
facility: Grand Strand Urology, LLP
state: South Carolina
city: Houston
country: United States
facility: M. D. Anderson Cancer Center at University of Texas
state: Texas
city: Houston
country: United States
facility: Dan L. Duncan Cancer Center at Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Toronto
country: Canada
facility: Edmond Odette Cancer Centre at Sunnybrook
state: Ontario
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Mark P. Schoenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: