Gene Therapy Clinical Trials

Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

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.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • procedure: computed tomography
  • procedure: cystoscopy
  • genetic: loss of heterozygosity analysis
  • genetic: microarray analysis
  • genetic: microsatellite instability analysis
  • other: cytology specimen collection procedure
  • other: laboratory biomarker analysis

Eligibility


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

Ages Eligible for Study

40 Years - 120 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ruth Lira
650723136
Not Recruiting