Evaluation of Chromosomal Genetic Abnormalities in Cells in Urine Using UroVysio
Not Applicable
- Conditions
- Bladder cancer
- Registration Number
- JPRN-UMIN000015194
- Lead Sponsor
- roVysion Domestic Japanese Clinical Performance Trial Steering Committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who may be unable to make the follow-up hospital visits Patients who now have or previously have demonstrable upper urinary tract cancer (renal pelvis or ureter cancer) or urethral cancer (including prostatic urethral cancer) Patients who have already participated in the trial once
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity in the detection of bladder cancer using UroVysion
- Secondary Outcome Measures
Name Time Method 1) Sensitivity and specificity in the detection of bladder cancer using urine cytology 2) The clinical and pathological factors affecting the sensitivity and specificity of UroVysion 3) The clinical and pathological factors affecting the sensitivity and specificity of urine cytology 4) Distribution of the UroVysion determinant factors (aneuploidy in chromosomes number 3, 7, and 17, and deletion of the 9p21 gene locus) in the pathology findings 5) Necessary parameters in the validation study of UroVysion determination criteria 1. Number of cells with increased multiple chromosomes 2. Number of cells with a 9p21 deletion