UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059301 |
|---|---|
| Receipt number | R000067828 |
| Scientific Title | Ancillary Study in Outcomes Research for Ulcerative Colitis using Patient Focused Registry |
| Date of disclosure of the study information | 2025/10/07 |
| Last modified on | 2025/10/07 12:50:54 |
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Basic information
Public title
Ancillary Study in Outcomes Research for Ulcerative Colitis using Patient Focused Registry
Acronym
You and Ulcerative Colitis: Registry and Social Network (YOURS)
Scientific Title
Ancillary Study in Outcomes Research for Ulcerative Colitis using Patient Focused Registry
Scientific Title:Acronym
You and Ulcerative Colitis: Registry and Social Network (YOURS)
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this 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 established in the preceding study, YOURS-001. :
1. To investigate the relationship between lifestyle factors and flare-ups in patients with ulcerative colitis in clinical remission.
2. Comprehensively evaluate changes in patient-reported outcomes (PRO)
Basic objectives2
Others
Basic objectives -Others
1. Investigate the association between lifestyle factors (alcohol consumption, exercise, smoking, sleep, etc.) and relapse or quality of life (QOL) in patients with ulcerative colitis in clinical remission
2. Describe changes in PRO-2 (Two-item Patient Reported Outcomes) over three years in patients with ulcerative colitis
3. Describe the three-year trajectory of comprehensive PROs in patients with ulcerative colitis, stratified by baseline disease severity. Comprehensive PRO measurements include SIBDQ, FACIT-F, HADS (depression and anxiety), WPAI (absenteeism, attendance, loss of work productivity, and activity impairment), and PSQI, among others.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Analysis of nutrient and dietary intake patterns
2.Analysis of changes in comprehensive PROs in patients with ulcerative colitis
Key secondary outcomes
1. Evaluation of lifestyle factors (exercise, sleep quality, smoking status, Oriental flush, etc.) in patients with and without disease flare-ups
2. Changes in comprehensive PROs according to disease severity, etc.
3. Changes in PRO-2 in the overall patient population
4. Evaluation of the association between lifestyle and quality of life
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 below requirement
1.Subjects enrolled in the YOURS-001 trial, Outcomes Research for Ulcerative Colitis using Patient Focused Registry, who have agreed to secondary use of their data
Key exclusion criteria
Subjects who meet the following criteria are not eligible for this clinical study.
1. Subjects who are judged as inappropriate by the research institution to participate in this trial
Target sample size
2006
Research contact person
Name of lead principal investigator
| 1st name | Katsuyoshi |
| Middle name | |
| Last name | Matsuoka |
Organization
Toho University Sakura Medical Center
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
285-8741
Address
564-1 Shimoshizu, Sakura, Chiba
TEL
042-462-8811
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
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
285-8741
Address
564-1 Shimoshizu, Sakura, Chiba
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
Ethics Committee, Toho University Faculty of Medicine
Address
5-21-16 Omorinishi, Ota City, Tokyo 143-8540, Japan
Tel
03-3762-4151
med.rinri@ext.toho-u.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
| 2025 | Year | 10 | Month | 07 | 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
| 2025 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable.
Management information
Registered date
| 2025 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067828
