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 | 2024/10/01 21:44:17 |
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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 | Katsuyoshi |
| Middle name | |
| Last name | Matsuoka |
Organization
Toho University Sakura Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
285-8741
Address
564-1 Shimoshizu, Sakura, Chiba 285-8741, Japan
TEL
043-462-8811
matsuoka@fk2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Katsuyoshi |
| Middle name | |
| Last name | Matsuoka |
Organization
Toho University Sakura Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
285-8741
Address
564-1 Shimoshizu, Sakura, Chiba 285-8741, Japan
TEL
043-462-8811
Homepage URL
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
Tokyo Medical and Dental University Ethihcal Committee
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519
Tel
03-5803-7102
syomu1.adm@tmd.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
東京科学大学病院(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
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036510
