UMIN-CTR Clinical Trial

Basic information
Public title	A prospective multicenter registry study of childhood cholestatic liver disease: Comprehensive and Informative Registry system for Childhood Liver disease (CIRCLe) study
Acronym	CIRCLe study
Scientific Title	A prospective multicenter registry study of childhood cholestatic liver disease: Comprehensive and Informative Registry system for Childhood Liver disease (CIRCLe) study
Scientific Title:Acronym	CIRCLe study
Region	Japan

Condition
Condition	Childhood cholestatic liver diseases
Classification by specialty	Hepato-biliary-pancreatic medicine Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Construction of registry database of childhood cholestatic liver diseases to understand their natural history and prognostic factors and facilitate future development of their therapeutic methods
Basic objectives2	Others
Basic objectives -Others	Collection of biological samples
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Survival period
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	1 days-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Subjects diagnosed with cholestatic liver diseases by 20-year-old 2) Subjects who have given written consent to participate in the study by themselves or their parents
Key exclusion criteria	1) Subjects who developed cholestatic liver disease after the age of 20 2) Subjects without written consent 3) Subjects judged to be inappropriate for this study by the researchers
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Hisamitsu Middle name Last name Hayashi
Organization	The University of Tokyo
Division name	Greaduate School of Pharmaceutical Sciences
Zip code	113-0033
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL	03-5841-4771
Email	cricle.registry@gmail.com

Public contact
Name of contact person	1st name Hisamitsu Middle name Last name Hayashi
Organization	The University of Tokyo
Division name	Greaduate School of Pharmaceutical Sciences
Zip code	113-0033
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL	03-5841-4771
Homepage URL	https://www.circle-registry.org/
Email	cricle.registry@gmail.com

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	Graduate School of Medicine and Faculty of Medicine, Ethics committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
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

弘前大学医学部附属病院（青森県）、秋田大学医学部附属病院(秋田県)、岩手医科大学（岩手県）、宮城県立こども病院（宮城県）、順天堂大学医学部附属順天堂医院（東京都）、東京大学医学部附属病院（東京都）、国立成育医療研究センター（東京都）、東京医科大学病院（東京都）、総合病院厚生中央病院（東京都）、筑波大学附属病院（茨城県）、信州大学医学部附属病院（長野県）、群馬大学医学部附属病院（群馬県）、自治医科大学附属病院（栃木県）、千葉県こども病院（千葉県）、千葉市立海浜病院（千葉県）、済生会横浜市東部病院（神奈川県）、埼玉県立小児医療センター（埼玉県）、獨協医科大学埼玉医療センター（埼玉県）、埼玉医科大学病院（埼玉県）、名古屋市立大学病院（愛知県）、磐田市立総合病院（静岡県）、小牧市民病院（愛知県）、大阪大学医学部附属病院（大阪府）、大阪母子医療センター（大阪府）、箕面市立病院（大阪府）、近畿大学奈良病院（奈良県）、京都大学医学部附属病院（京都府）、兵庫県立尼崎総合医療センター（兵庫県）、兵庫医科大学病院（兵庫県）、金沢医科大学病院（石川県）、鳥取大学医学部附属病院（鳥取県）、津山中央病院（岡山県）、山口大学医学部附属病院（山口県）、香川大学医学部附属病院（香川県）、久留米大学病院（福岡県）、九州大学病院（福岡県）、佐賀大学医学部附属病院（佐賀県）、熊本労災病院（熊本県）、熊本赤十字病院（熊本県）

Other administrative information
Date of disclosure of the study information	2021 Year 02 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	Open public recruiting
Date of protocol fixation	2020 Year 06 Month 01 Day
Date of IRB	2020 Year 07 Month 01 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2025 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Cohort of this study is patients with childhood cholestatic liver disease other than biliary atresia. This research lasts for many years, but will be reviewed and changed every five years. The patients are registered as much as possible without limiting the number of cases. In the first five years, approximately 800 cases will be registered from 39 institutions with pediatric hepatologists. This study evaluates survival period and its related items.

Management information
Registered date	2021 Year 01 Month 27 Day
Last modified on	2021 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045612