UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058934 |
|---|---|
| Receipt number | R000067400 |
| Scientific Title | Prognostic impact of MES 1 inflammatory extent on remission maintenance in ulcerative colitis |
| Date of disclosure of the study information | 2025/08/29 |
| Last modified on | 2025/08/29 20:44:24 |
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Basic information
Public title
Prognostic impact of MES 1 inflammatory extent on remission maintenance in ulcerative colitis
Acronym
Prognostic impact of MES 1 inflammatory extent on remission maintenance in ulcerative colitis
Scientific Title
Prognostic impact of MES 1 inflammatory extent on remission maintenance in ulcerative colitis
Scientific Title:Acronym
Prognostic impact of MES 1 inflammatory extent on remission maintenance in ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to retrospectively analyze the impact of the extent of inflammation distribution on the remission maintenance rate in patients with UC evaluated as MES 1 and to reevaluate whether all MES 1 inflammation should be treated equally or not.
Basic objectives2
Others
Basic objectives -Others
The aim of this study was to retrospectively analyze the impact of the extent of inflammation distribution on the remission maintenance rate in patients with UC evaluated as MES 1 and to reevaluate whether all MES 1 inflammation should be treated equally or not.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of this study is to evaluate the two-year clinical remission maintenance rate based on the extent of inflammation classified as MES 1.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with UC who were treated at the Department of Gastroenterology, Dokkyo Medical University Hospital between January 1, 2008, and December 31, 2023, had an MES of 0 or 1 at the initial endoscopic assessment after remission induction therapy without any change in remission maintenance therapy, and had available follow-up data for two years after the endoscopy were enrolled.
Key exclusion criteria
The following cases were excluded from the study: cases with left-sided colitis or proctitis; cases in which no endoscopic examination was performed after remission induction; cases in which total colonoscopy was not performed; cases that had an MES of 2 or 3 at the initial endoscopic assessment after remission induction therapy; cases in which the clinical course could not be followed for two years after endoscopy; cases with a history of colonic surgery; cases receiving immunosuppressive therapy for other diseases; cases in which the patient refused to participate in the study; and cases deemed inappropriate for inclusion in this study by the investigators.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Mimari |
| Middle name | |
| Last name | Kanazawa |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
3210293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL
+81-282-87-2147
mimari77@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Mimari |
| Middle name | |
| Last name | Kanazawa |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
3210293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL
+81-282-87-2147
Homepage URL
mimari77@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
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
The ethics committee of Dokkyo Medical University Hospital
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
Tel
+81-282-87-2147
r-kenkyu@dokkyomed.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
| 2025 | Year | 08 | Month | 29 | 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
301
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
| 2025 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2025 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067400
