UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical features, prognostic factors and outcomes of urothelial cancer: Retrospective study
Title of the study (Brief title)	Retrospective registration study on urothelial cancer
Region	Japan

Condition
Condition	urothelial cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigating an impact of clinicopathological features on oncological outcomes of urothelial cancers in Gunma University Hospital.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Outcomes in terms of complete resection, recurrence, progression to invasive cancer or metastatic cancer, cause-specific survival and overall survival
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed with urothelial cancer in Gunma University Hospital between January 1st, 2005 and December 31, 2020
Key exclusion criteria	1) Men who refuse to participate in the study 2) Men whom researchers judge to inappropriate to participate in the study
Target sample size	1000

Research contact person
Name of lead principal investigator	Kazuhiro Suzuki
Organization	Gunma University Hospital
Division name	Urology
Address	3-39-22, Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8303
Email	kazu@gunma-u.ac.jp

Public contact
Name of contact person	Atusuko Ohyama
Organization	Gunma University Graduate School of Medicine
Division name	Urology
Address	3-39-22, Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8303
Homepage URL
Email	a-ohyama@gunma-u.ac.jp

Sponsor
Institute	Department of Urology, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Urology, Gunma University Graduate School of Medicine
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	2016 Year 01 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 12 Month 22 Day
Anticipated trial start date	2016 Year 01 Month 01 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	The purpose of the present retrospective study is investigating an impact of clinicopathological features on oncological outcomes of urothelial cancers in Gunma University Hospital Declare outcomes and complications of urothelial cancer in Gunma University Hospital and exploring prognostic factors of urothelial cancer may contribute progress in medicine in this field.

Management information
Registered date	2015 Year 12 Month 02 Day
Last modified on	2018 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023141