UMIN-CTR Clinical Trial

Basic information
Public title	Case-control study of Autoimmune hepatitis and Primary Biliary Cholangitis
Acronym	Case-control study of Autoimmune hepatitis and Primary Biliary Cholangitis
Scientific Title	Case-control study of Autoimmune hepatitis and Primary Biliary Cholangitis
Scientific Title:Acronym	Case-control study of Autoimmune hepatitis and Primary Biliary Cholangitis
Region	Japan

Condition
Condition	Autoimmune hepatitis Primary Biliary Cholangitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Purpose of identifying environmental factors involved in the development of PBC and AIH
Basic objectives2	Others
Basic objectives -Others	Identification of disease-causing factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of diseases affected by environmental factors (Artificial statistical / socio-economic characteristics, lifestyle, medical history, family history, surgical history, vaccination history, women's events)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Case Primary Biliary Cholangitis or Autoimmune hepatitis was confirmed by the diagnostic criteria of the "Investigative Research on The Intractable Hepato-Biliary Diseases" group of the Health Labor Science research Grants from Research on Measures for intractable Diseases, and is currently at Teikyo University Hospital, or Among patients who are outpatients or inpatients to other facilities belonging to the research organization of this study, those who have consented to participate in this study. Control Patients who meet the following three conditions and are currently outpatient or inpatient at Teikyo University Hospital or another facility belonging to the research organization of this research. The gender and age of the patient match. Not suffering from PBC, AIH, and other autoimmune diseases. A member of the research organization is the attending physician.
Key exclusion criteria	PBC/AIH atypical cases or overlapping cases. Patients under 20 years old. Other patients who are judged to be inappropriate for research participation.
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Tanaka
Organization	Teikyo University School of Medicine
Division name	Internal medicine
Zip code	173-8605
Address	2-11-1 Kaga, Itabashi City, Tokyo 173-8605
TEL	03-3964-1211
Email	a-tanaka@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Kosuke Middle name Last name Matsumoto
Organization	Teikyo University School of Medicine
Division name	Internal medicine
Zip code	173-8605
Address	2-11-1 Kaga, Itabashi City, Tokyo 173-8605
TEL	03-3964-1211
Homepage URL
Email	m-kosuke0716@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	None
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	Teikyo University Medical Research Ethics Committee
Address	2-11-1 Kaga, Itabashi City, Tokyo 173-8605
Tel	03-3964-7256
Email	turb-office@teikyo-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	2021 Year 01 Month 09 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	2020 Year 08 Month 06 Day
Date of IRB	2020 Year 08 Month 06 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Research method Ask study participants who have agreed in writing to participate in the study to access the constructed Electronic Data Capture System and enter answers to the questions related to the listed environmental factors. Participants who have difficulty using EDC will be asked to distribute a questionnaire and return envelope, fill it out, and mail it. Integrate the information entered into the EDC by study participants and the information in the mailed questionnaire and statistically compare AIH patients with control patients and PBC patients with control patients.

Management information
Registered date	2021 Year 01 Month 09 Day
Last modified on	2021 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049036

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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