UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031995
Receipt number 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 13:55:07

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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 or person

Institute

Takeda Pharmaceutical Company, Limited

Institute

Department

Personal name



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

Value
https://center6.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