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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039131
Receipt No. R000044629
Scientific Title Features in Japanese Patients with Inflammatory Bowel Diseases : A multicenter prospective long observational study
Date of disclosure of the study information 2020/01/11
Last modified on 2020/01/17

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Basic information
Public title Features in Japanese Patients with Inflammatory Bowel Diseases : A multicenter prospective long observational study
Acronym Far East 1000
Scientific Title Features in Japanese Patients with Inflammatory Bowel Diseases : A multicenter prospective long observational study
Scientific Title:Acronym Far East 1000
Region
Japan

Condition
Condition Inflammatory Bowel Disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate the disease status, medications, and complications of IBD, which has been rapidly increasing in Japan in recent years, over a long period of time.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. History of medication and incidence of relapse in IBD patients.
2. Incidence of complications in IBD patients.
3. Changes in age of onset of IBD patients.
4. Complication rate of PSC in IBD patients and usefulness of surveillance in MRCP.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with inflammatory bowel disease
2. Patients of any age
3. Patients who agree to participate this study after receiving an explanation and providing consent forms
Key exclusion criteria 1. Patients who refused to participate in this study
2. Patients judged to be ineligible by the research director
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name Kato
Organization Chiba University Hospital
Division name Gastoroenterology
Zip code 2600856
Address 1-8-1, Inohana, Chuo-ku, Chiba city, Chiba prefecture, Japan
TEL 043-222-7171
Email kato.naoya@chiba-u.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Ohta
Organization Chiba University Hospital
Division name Gastoroenterology
Zip code 2600856
Address 1-8-1, Inohana, Chuo-ku, Chiba city, Chiba prefecture, Japan
TEL 043-222-7171
Homepage URL
Email ohta.yuki@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research ethics committee of the graduate school of medicine, Chiba university
Address 1-8-1, Inohana, Chuo-ku, Chiba city, Chiba prefecture, Japan
Tel 043-226-2841
Email igaku-rinri@office.chiba-u.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 01 Month 11 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
2018 Year 10 Month 14 Day
Date of IRB
2018 Year 07 Month 18 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2029 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1st data fixation on 30th September 2019.

Management information
Registered date
2020 Year 01 Month 11 Day
Last modified on
2020 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044629

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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