Evaluation of Chromosomal Genetic Abnormalities in Cells in Urine Using UroVysion

Evaluation of Chromosomal Genetic Abnormalities in Cells in Urine Using UroVysion - UroVysion Domestic Japanese Clinical Performance Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015194

Enrollment

450

Registered

2014-09-17

Start date

2014-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults of age 20 or older Patients having a history of bladder cancer within the past 2 years Patients scheduled for cystoscopy and urine cytology exam Consent form obtained

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity in the detection of bladder cancer using UroVysion	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactYutaka Seki

Abbott Japan Co., Ltd. Molecular Business Development Dept

yutaka.seki@abbott.com03-4555-1099

Outcome results