UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the mechanism of bladder recurrence after nephroureterectomy
Title of the study (Brief title)	Study of the mechanism of bladder recurrence after nephroureterectomy
Region	Japan

Condition
Condition	Upper urinary tract urothelial carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Study of the mechanism of bladder recurrence of nephroureterectomy
Basic objectives2	Others
Basic objectives -Others	the mechanism of bladder recurrence
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	bladder recurrence
Key secondary outcomes	pathology

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Upper urinary tract urothelial carcinoma
Key exclusion criteria	Past history of bladder cancer
Target sample size	50

Research contact person
Name of lead principal investigator	Takeshi Azuma
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Urology
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo , Japan
TEL	042-323-5111
Email	tazuma-tky@umin.a.cjp

Public contact
Name of contact person	Takeshi Azuma
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Urology
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo , Japan
TEL	042-323-5111
Homepage URL
Email	tazuma-tky@umin.ac.jp

Sponsor
Institute	Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Tama Medical Center
Organization
Division
Category of Funding Organization	Other
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	2018 Year 01 Month 27 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 01 Month 25 Day
Anticipated trial start date	2018 Year 01 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	nothing

Management information
Registered date	2018 Year 01 Month 26 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035395