UMIN-CTR Clinical Trial

Basic information
Public title	Disease registry of primary sclerosing cholangitis
Acronym	Disease registry of primary sclerosing cholangitis
Scientific Title	Establishment of disease registry of primary sclerosing cholangitis for investigation of clinical features, natural history, and prognostic factors; RADDAR-J [13]
Scientific Title:Acronym	Disease registry of primary sclerosing cholangitis
Region	Japan

Condition
Condition	Primary sclerosing cholangitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	1) We aim to prospectively register clinical information, sera, and DNA of patients with primary sclerosing cholangitis (PSC) in Japan and to establish comprehensive as well as long-standing PSC registry.
Basic objectives2	Others
Basic objectives -Others	2) With the PSC resigtry in Japan, we also aim to clarify clinical characteristics, natural history and prognostic factors of PSC.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Death or liver transplantation
Key secondary outcomes	1) developmenet of cholangiocarcinoma or colorectal cancer 2) develpment of clinical events including bacterial cholangitis, jaundice 3) progression of liver fibrosis 4) EQ-5D-5L

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	1) Patients who were diagnosed as primary sclerosing cholangitis (definite or probable) with the MHLW criteria 2) Patients who gave informed consent to participate in this study
Key exclusion criteria	1) Patients who were diagnosed as primary sclerosing cholangitis (possible) with the MHLW criteria 2) Patients who were diagnosed as IgG4-related sclerosing cholangitis or secondary sclerosing cholangitis
Target sample size	2300

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Tanaka
Organization	Teikyo University School of Medicine
Division name	Department of Medicine
Zip code	1738605
Address	2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL	0339641211
Email	a-tanaka@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Kayono Middle name Last name Unno
Organization	Teikyo University School of Medicine
Division name	Department of Medicine
Zip code	1738605
Address	2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL	0339641211
Homepage URL
Email	k-unno@med.teikyou.ac.jp

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	The Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.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

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 01 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	Enrolling by invitation
Date of protocol fixation	2019 Year 08 Month 07 Day
Date of IRB	2019 Year 09 Month 24 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is; 1)To prospectively register patients with PSC 2) To collect clinical information at baseline and every year thereafter 3) To collect DNA of the patients 4) To collect serum and plasma of the patients at baseline and every year thereafter

Management information
Registered date	2020 Year 03 Month 19 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045482