Unique ID issued by UMIN | UMIN000015194 |
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Receipt number | R000017663 |
Scientific Title | Evaluation of Chromosomal Genetic Abnormalities in Cells in Urine Using UroVysion |
Date of disclosure of the study information | 2014/09/17 |
Last modified on | 2017/02/10 14:25:37 |
Evaluation of Chromosomal Genetic Abnormalities in Cells in Urine Using UroVysion
UroVysion Domestic Japanese Clinical Performance Trial
Evaluation of Chromosomal Genetic Abnormalities in Cells in Urine Using UroVysion
UroVysion Domestic Japanese Clinical Performance Trial
Japan |
Bladder cancer
Urology |
Malignancy
NO
Investigate the utility of UroVysion in detecting bladder cancer recurrence using urine from patients with a history of bladder cance.
Others
Accuracy in the diagnosis of bladder cancer
Sensitivity and specificity in the detection of bladder cancer using UroVysion
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
450
1st name | |
Middle name | |
Last name | Seiichiro Ozono |
Hamamatsu University School of Medicine
Department of Urology
1-20-1 Handayama, Higashi-ku, Hamamatsu city
053-435-2306
oznsei@hama-med.ac.jp
1st name | |
Middle name | |
Last name | Yutaka Seki |
Abbott Japan Co., Ltd.
Molecular Business Development Dept
3-5-27 Mita, Minato-ku, Tokyo
03-4555-1099
yutaka.seki@abbott.com
UroVysion Domestic Japanese Clinical Performance Trial Steering Committee
Abbott Japan Co., Ltd.
Profit organization
NO
2014 | Year | 09 | Month | 17 | Day |
Unpublished
Completed
2014 | Year | 06 | Month | 18 | Day |
2014 | Year | 09 | Month | 01 | Day |
2016 | Year | 06 | Month | 13 | Day |
2016 | Year | 06 | Month | 30 | Day |
Sensitivity and Specificity
2014 | Year | 09 | Month | 17 | Day |
2017 | Year | 02 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017663
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