UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015194 |
|---|---|
| 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 |
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Basic information
Public title
Evaluation of Chromosomal Genetic Abnormalities in Cells in Urine Using UroVysion
Acronym
UroVysion Domestic Japanese Clinical Performance Trial
Scientific Title
Evaluation of Chromosomal Genetic Abnormalities in Cells in Urine Using UroVysion
Scientific Title:Acronym
UroVysion Domestic Japanese Clinical Performance Trial
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the utility of UroVysion in detecting bladder cancer recurrence using urine from patients with a history of bladder cance.
Basic objectives2
Others
Basic objectives -Others
Accuracy in the diagnosis of bladder cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity in the detection of bladder cancer using UroVysion
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiichiro Ozono |
Organization
Hamamatsu University School of Medicine
Division name
Department of Urology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city
TEL
053-435-2306
oznsei@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Seki |
Organization
Abbott Japan Co., Ltd.
Division name
Molecular Business Development Dept
Zip code
Address
3-5-27 Mita, Minato-ku, Tokyo
TEL
03-4555-1099
Homepage URL
yutaka.seki@abbott.com
Sponsor or person
Institute
UroVysion Domestic Japanese Clinical Performance Trial Steering Committee
Institute
Department
Personal name
Funding Source
Organization
Abbott Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 06 | Month | 13 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Sensitivity and Specificity
Management information
Registered date
| 2014 | Year | 09 | Month | 17 | Day |
Last modified on
| 2017 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017663
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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