UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043148
Receipt number R000045612
Scientific Title A prospective multicenter registry study of childhood cholestatic liver disease: Comprehensive and Informative Registry system for Childhood Liver disease (CIRCLe) study
Date of disclosure of the study information 2021/02/01
Last modified on 2021/01/27 14:05:56

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

The University of Tokyo

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045612


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name