Clinical trial · Observational
Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study
NCT00095589CI-TRIAL-00036995completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| cystoscopy | Procedure | — | UNRESOLVED |
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| loss of heterozygosity analysis | Genetic | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
| microsatellite instability analysis | Genetic | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.