UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063246 |
|---|---|
| Receipt number | R000072391 |
| Scientific Title | Clinical Course to Remission from Initial Treatment in Patients with Inflammatory Bowel Disease |
| Date of disclosure of the study information | 2026/10/13 |
| Last modified on | 2026/10/12 13:04:39 |
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Basic information
Public title
Clinical Course to Remission from Initial Treatment in Patients with Inflammatory Bowel Disease
Acronym
Study on the Clinical Course of Inflammatory Bowel Disease
Scientific Title
Clinical Course to Remission from Initial Treatment in Patients with Inflammatory Bowel Disease
Scientific Title:Acronym
Study on the Clinical Course of Inflammatory Bowel Disease
Region
| Japan |
Condition
Condition
Ulcerative colitis, Crohn's disease
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This retrospective observational study aims to investigate the clinical course to remission in patients with newly diagnosed inflammatory bowel disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Basic Patient Information: Age, Sex, Diagnosis, Medical History, Family History, Medical Treatment History
2. Physical Examination Findings
3. Laboratory/Diagnostic Test Results (Blood tests, Imaging studies, Endoscopic findings, Stool tests, Pathological findings)
4. Time to Remission (Days to Remission)
5. Hospitalization Rate
6. Rate of Steroid and Biologic Initiation
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients newly diagnosed with ulcerative colitis or Crohn's disease at our department
2. Patients diagnosed with ulcerative colitis or Crohn's disease within 1 year prior to referral to our department
Key exclusion criteria
Patients deemed unsuitable for the study by the principal investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Yano |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Gastroenterology
Zip code
279-0021
Address
2-1-1 Tomioka,Urayasu-shi,Chiba,Japan
TEL
047-353-3111
shi-yano@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Yano |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Gastroenterology
Zip code
279-0021
Address
2-1-1 Tomioka,Urayasu-shi,Chiba,Japan
TEL
047-353-3111
Homepage URL
shi-yano@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Kakenhi
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Urayasu Hospital Ethics Committee Secretariat
Address
2-1-1 Tomioka Urayasu Chiba
Tel
047-353-3111
rinri-urayasu@juntendo-urayasu.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
| 2026 | Year | 10 | Month | 13 | 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
| 2021 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study investigates the clinical course to remission and changes in endoscopic findings in treatment-naive patients with ulcerative colitis and Crohn's disease.
Management information
Registered date
| 2026 | Year | 10 | Month | 12 | Day |
Last modified on
| 2026 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072391
