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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031995
Receipt No. R000036510
Scientific Title Outcomes Research for Ulcerative Colitis using Patient Focused Registry
Date of disclosure of the study information 2018/03/31
Last modified on 2019/04/15

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Basic information
Public title Outcomes Research for Ulcerative Colitis using Patient Focused Registry
Acronym You and Ulcerative Colitis: Registry and Social Network
Scientific Title Outcomes Research for Ulcerative Colitis using Patient Focused Registry
Scientific Title:Acronym You and Ulcerative Colitis: Registry and Social Network
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of the study is to clarify the below 4 points leading to the Outcome improvement (patient report type of outcome such as QOL, recurrence and deterioration, hospitalization and remove of the whole large bowel) by using patient-centric registry.(Figure 1)
1. Relation between Daily life customs(meals, sleeping, exercise etc.) and outcome
2. Relation between Factor of phytosociology(depression, social support etc) and outcome
3. Relation between diagnosis pattern (medical agent, blood drawing, stool inspection and endoscope) and outcome
4. Relation between medical parties and patients on the gap of consciousness for problem and outcome
Basic objectives2 Others
Basic objectives -Others Patient reported outcomes on treatment pattern and effectiveness
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mainly following 4 endpoints will be evaluated as outcomse, but all observed endpoints can be outcomes because of observational study.
1. Flare / Exacerbation
2. Hospitalization
3. Surgical operation (total proctocolectomy, etc.)
4. Patient-reported outcomes (QoL, etc.)
Key secondary outcomes Not noted because of registry.

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects who fills all below requirement
1. Subjects who were judged by the investigators capable to understand the contents of this clinical research and comply with them
2. Subjects who are able to sign and date the Informed Consent Form before any clinical research procedure begins
3. Subjects who is diagnosed as ulcerative colitis according to the "revised version of diagnosis standard of ulcerative colitis therapy (H.27) of "investigational study related to refractory case of inflammatory intestine disorder "
4. Subjects who is over 16 years old at the acquisition of consensus
5. Subjects who is going to the study intuition.
Key exclusion criteria 1. Subjects who cannot obtain consensus on this study
2. Subjects who are judged as inappropriate by researcher etc. in each facility
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyoshi Matsuoka
Organization Toho University Sakura Medical Center
Division name Department of Gastroenterology and Hepatology
Zip code
Address 564-1 Shimoshizu, Sakura, Chiba 285-8741, Japan
TEL 043-462-8811
Email matsuoka@fk2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyoshi Matsuoka
Organization Toho University Sakura Medical Center
Division name Department of Gastroenterology and Hepatology
Zip code
Address 564-1 Shimoshizu, Sakura, Chiba 285-8741, Japan
TEL 043-462-8811
Homepage URL
Email matsuoka@fk2.so-net.ne.jp

Sponsor
Institute Takeda Pharmaceutical Company, Limited
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company, Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Japanese Society for Inflammatory Bowel Disease
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京医科歯科大学病院(東京都)、杏林大学病院(東京都)、北里大学北里研究所病院(東京都)、東邦大学医療センター佐倉病院(千葉県)、東京女子医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 31 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 No longer recruiting
Date of protocol fixation
2018 Year 02 Month 24 Day
Date of IRB
2018 Year 03 Month 27 Day
Anticipated trial start date
2018 Year 05 Month 31 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Flare / Exacerbation
2. Hospitalization
3. Surgical operation (total proctocolectomy, etc.)
4. Patient reported outcomes (QoL, etc.)

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036510

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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