UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039795 |
|---|---|
| Receipt number | R000045384 |
| Scientific Title | Analysis of the immunological conditions in the intestinal mucosa of inflammatory bowel disease |
| Date of disclosure of the study information | 2020/03/12 |
| Last modified on | 2025/03/17 12:44:46 |
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Basic information
Public title
Analysis of the immunological conditions in the intestinal mucosa of inflammatory bowel disease
Acronym
IBD immunological analysis
Scientific Title
Analysis of the immunological conditions in the intestinal mucosa of inflammatory bowel disease
Scientific Title:Acronym
IBD immunological analysis
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the immunological conditions in inflammatory bowel disese patients especially in the Peyer's patch.
Basic objectives2
Others
Basic objectives -Others
To analyze the relations between the pathogenesis and immunological condition in the mucosa
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The percentages of immune-related cell types infiltrating the mucosa
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 year old or more
2) patients planned with colonoscopy
Key exclusion criteria
1) decided as not proper for mucosal biopsy according to the guideline of the hospital by the attending doctor
2) decided as not proper for some reasons by the attending doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Matsushima |
Organization
Tokai University School of Medicine
Division name
Internal Medicine (gastroenterlogy)
Zip code
259-1193
Address
143 Shimokasuya, Isehara, 2591193 Japan
TEL
0463931121
mmatsush@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Matsushima |
Organization
Tokai University School of Medicine
Division name
Internal Medicine (gastroenterlogy)
Zip code
259-1193
Address
143 Shimokasuya, Isehara, 2591193 Japan
TEL
0463931121
Homepage URL
mmatsush@tokai.ac.jp
Sponsor or person
Institute
Internal Medicine (gastroenterlogy)
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
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
Institutional review board of clinical research, Tokai University
Address
143 Shimokasuya, Isehara, 259-1193 Japan
Tel
0463931121
mmatsush@tokai.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
| 2020 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Immunohistocheical amalyses were not preformed with no precise protocol.
Publication of results
Unpublished
Result
URL related to results and publications
The study was quited before any analysis.
Number of participants that the trial has enrolled
5
Results
The study was quited without immunohistochemical analysis.
Results date posted
| 2025 | Year | 03 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
IBD and non-IBD patiets who received total colonoscopy.
Participant flow
During colonoscopy, biopsy samples were obtained from terminal ileum. The samples were used for later immunohistochemical analyses.
Adverse events
none
Outcome measures
Infiltration of immune-related cells to the tissues.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze the relations between the disease states and immunological states in the specimen using immunohistochemistry and flow cytemetry
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045384
