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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042954
Receipt No. R000049036
Scientific Title Case-control study of Autoimmune hepatitis and Primary Biliary Cholangitis
Date of disclosure of the study information 2021/01/09
Last modified on 2021/01/09

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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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