UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Chromosomal Genetic Abnormalities in Cells in Urine Using UroVysion
Title of the study (Brief title)	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	Seiichiro Ozono
Organization	Hamamatsu University School of Medicine
Division name	Department of Urology
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city
TEL	053-435-2306
Email	oznsei@hama-med.ac.jp

Public contact
Name of contact person	Yutaka Seki
Organization	Abbott Japan Co., Ltd.
Division name	Molecular Business Development Dept
Address	3-5-27 Mita, Minato-ku, Tokyo
TEL	03-4555-1099
Homepage URL
Email	yutaka.seki@abbott.com

Sponsor
Institute	UroVysion Domestic Japanese Clinical Performance Trial Steering Committee
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017663