Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

Johns Hopkins Medicine

Status: Completed

Conditions: Bladder Cancer

Treatments: Genetic: loss of heterozygosity analysis; Other: laboratory biomarker analysis; Genetic: microarray analysis; Procedure: computed tomography; Procedure: cystoscopy; Genetic: microsatellite instability analysis; Other: cytology specimen collection procedure

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00095589

U01CA084968 (U.S. NIH Grant/Contract)

P30CA006973 (U.S. NIH Grant/Contract)

CDR0000401496 (Other Identifier)

J0382

03-12-30-05 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 40 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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