UMIN-CTR Clinical Trial

Basic information
Public title	Comprehensive clinical research regarding treatment outcomes and elucidation of pathological conditions in patients with pediatric urological disease
Acronym	Comprehensive clinical research regarding treatment outcomes and elucidation of pathological conditions in patients with pediatric urological disease
Scientific Title	Comprehensive clinical research regarding treatment outcomes and elucidation of pathological conditions in patients with pediatric urological disease
Scientific Title:Acronym	Comprehensive clinical research regarding treatment outcomes and elucidation of pathological conditions in patients with pediatric urological disease
Region	Japan

Condition
Condition	pediatric urological disease
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate treatment outcomes, natural history and pathological conditions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The success rate of treatment for pediatric urological disease
Key secondary outcomes	age, sex, height, weight, symptoms, clinical events, duration between referral date and surgery, clinical data (blood, urine, etc), radiological findings, surgical findings, pathological finding, chromosomal exam

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	1 days-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	The Patients with the pediatric urological disease who visit Nagoya City University Hospital from January 1, 2004, to December 31, 2027
Key exclusion criteria	The patients who denied this clinical research and did not give consent for this clinical research
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Mizuno Middle name Last name Kentaro
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Pediatric Urology
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-851-5511
Email	kmizuno@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Mizuno Middle name Last name Kentaro
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Pediatric Urology
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-851-5511
Homepage URL
Email	kmizuno@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Management Center, Nagoya City University Hospital
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel	052-858-7215
Email	clinical_research@med.nagoya-cu.ac.jp

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	名古屋市立大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2022 Year 10 Month 13 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	Open public recruiting
Date of protocol fixation	2022 Year 07 Month 26 Day
Date of IRB	2022 Year 07 Month 26 Day
Anticipated trial start date	2022 Year 07 Month 26 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Collection of information about patients with pediatric urological disease from electrical medical records

Management information
Registered date	2022 Year 10 Month 13 Day
Last modified on	2022 Year 10 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056043