UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063382 |
|---|---|
| Receipt number | R000072412 |
| Scientific Title | Intestinal mucin glycosylation and clinical relapse in ulcerative colitis in remission: a single-center prospective observational study |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/23 08:22:08 |
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Basic information
Public title
Intestinal mucin and relapse in patients with ulcerative colitis in remission
Acronym
Intestinal mucin and relapse in patients with ulcerative colitis in remission
Scientific Title
Intestinal mucin glycosylation and clinical relapse in ulcerative colitis in remission: a single-center prospective observational study
Scientific Title:Acronym
Intestinal mucin glycosylation and clinical relapse in ulcerative colitis in remission: a single-center prospective observational study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate intestinal mucin at the glycan level in the colonic mucosa of patients with ulcerative colitis in remission. To examine whether its expression predicts subsequent clinical relapse.
Basic objectives2
Others
Basic objectives -Others
Exploration of a prognostic factor for relapse risk (examining whether intestinal mucin expression predicts future disease course, rather than evaluating treatment efficacy or diagnostic performance)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between intestinal mucin expression and clinical relapse in patients with ulcerative colitis in remission.
Key secondary outcomes
Difference in intestinal mucin expression between patients in remission and those with active disease
Association of endoscopic severity and endoscopic images with intestinal mucin expression
Association between changes in disease activity and intestinal mucin expression within the same patient
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older who were diagnosed with and treated for ulcerative colitis at Kitasato University Hospital and underwent colonoscopy.
Key exclusion criteria
1. Patients who have undergone or are scheduled for surgical resection for ulcerative colitis
2. Patients with ulcerative proctitis
3. Patients who cannot attend long-term follow-up
4. Pregnant or breastfeeding women
5. Patients who do not provide informed consent
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Kusano |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
ckusano@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Horii |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
0117221110
Homepage URL
horii.toshiki@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine and Hospital Ethics Committee
Address
1-15-1 Kitasato, Minami-ku, Sagamihara
Tel
0117221110
rinrib@med.kitasato-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center, prospective longitudinal study. Additional colonic mucosal biopsies for research are obtained during colonoscopy performed as part of routine clinical care. Mucin glycan expression in the intestinal mucosa is analyzed at the Department of Pathophysiological Biochemistry, Kitasato University School of Allied Health Sciences. Clinical severity, treatment, blood test results, endoscopic findings, and histological findings are collected from medical records for up to 108 weeks after colonoscopy.
Management information
Registered date
| 2026 | Year | 10 | Month | 23 | Day |
Last modified on
| 2026 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072412
