UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061595 |
|---|---|
| Receipt number | R000070454 |
| Scientific Title | Molecular, Cellular, and Spatial Analysis of Granulomas in Crohn's Disease |
| Date of disclosure of the study information | 2026/05/25 |
| Last modified on | 2026/05/16 12:47:39 |
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Basic information
Public title
Molecular, Cellular, and Spatial Analysis of Granulomas in Crohn's Disease
Acronym
Molecular, Cellular, and Spatial Analysis of Granulomas in Crohn's Disease
Scientific Title
Molecular, Cellular, and Spatial Analysis of Granulomas in Crohn's Disease
Scientific Title:Acronym
Molecular, Cellular, and Spatial Analysis of Granulomas in Crohn's Disease
Region
| Japan |
Condition
Condition
Crohn's Disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to elucidate the following three aspects of granulomas formed in intestinal tissues and regional lymph nodes of patients with Crohn's disease:
1. To identify microbial-derived and host-derived antigens within granulomas and their surrounding tissues.
2. To investigate host response abnormalities in granulomas within and between patients.
3. To extract mechanistic features of host response abnormalities related to phagocytosis, antigen processing, and inflammatory regulation.
Basic objectives2
Others
Basic objectives -Others
Pathogenesis/Basic research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Types and localization of antigens, cellular profiles of granuloma constituents, and expression of molecules related to phagocytosis, antigen processing, and inflammatory regulation in granuloma tissues
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited Kitasato University Kitasato Institute Hospital and meet all of the following criteria:
1. Patients aged 18 years or older with a diagnosis of Crohn's disease
2. Patients from whom tissue specimens have been obtained by surgical resection or endoscopic biopsy
3. Patients in whom granuloma formation has been pathologically confirmed, and whose residual tissue specimens are preserved after completion of diagnostic procedures
Key exclusion criteria
Patients who meet any of the following criteria
1. Patients from whom written informed consent cannot be obtained
2. Patients deemed unsuitable for study participation by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1 Shirokane Minato-ku, Tokyo, Japan
TEL
03-3444-6161
drkobataku@gmail.com
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Morihisa |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Gastroenterology
Zip code
108-8642
Address
5-9-1 Shirokane Minato-ku, Tokyo, Japan
TEL
03-3444-6161
Homepage URL
morihisa.yoshiki@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Kitasato Institute Hospital
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
Research Ethics Committee, Kitasato Institute Hospital
Address
5-9-1 Shirokane Minato-ku, Tokyo, Japan
Tel
03-5791-6106
kenkyu@insti.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 | 05 | Month | 25 | 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 | 04 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study conducted jointly by three institutions: Kitasato University Kitasato Institute Hospital, Kitasato University School of Pharmacy, and the Research Organization for Nano & Life Innovation, Waseda University. Residual specimens and clinical information obtained during routine clinical care will be used for patients who provide written informed consent. The study results will be published in academic journals and presented at academic conferences.
Management information
Registered date
| 2026 | Year | 05 | Month | 16 | Day |
Last modified on
| 2026 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070454
