UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A nation-wide survey of sclerosing cholangitis in Japan
Title of the study (Brief title)	A nation-wide survey of sclerosing cholangitis in Japan
Region	Japan

Condition
Condition	sclerosing cholangitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To survey general features of primary sclerosing cholangitis and IgG4-related sclerosing cholangitis in Japan
Basic objectives2	Others
Basic objectives -Others	epidemiological study
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Number of new cases, clinical features, treatment and prognosis of patients with PSC and IgG4-SC in referral centers in Japan
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	Diagnosed as PSC or IgG4-SC
Key exclusion criteria	N/A
Target sample size	500

Research contact person
Name of lead principal investigator	Atsushi Tanaka
Organization	Teikyo University School of Medicine
Division name	Dept of Medicine
Address	2-11-1,kaga,Itabashi-ku
TEL	03(3964)1211
Email	a-tanaka@med.teikyo-u.ac.jp

Public contact
Name of contact person	Atsushi Tanaka
Organization	Teikyo University School of Medicine
Division name	Dept of Medicine
Address	2-11-1,kaga,Itabashi-ku
TEL	03(3964)1211
Homepage URL
Email	a-tanaka@med.teikyo-u.ac.jp

Sponsor
Institute	the Intractable Hepato-Biliary Diseases Study Group in Japan
Institute
Department

Funding Source
Organization	MHLW
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2015 Year 07 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 27 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2015 Year 09 Month 30 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 01 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	In this study we will collect clinical information of patients with PSC or IgG4-SC in Japan.

Management information
Registered date	2015 Year 07 Month 27 Day
Last modified on	2018 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021349