UMIN-CTR Clinical Trial

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