UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055385 |
|---|---|
| Receipt number | R000063228 |
| Scientific Title | Evaluation of intestinal mucosa in patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/09/02 08:10:57 |
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Basic information
Public title
Evaluation of intestinal mucosa in patients with inflammatory bowel disease
Acronym
Evaluation of intestinal mucosa in patients with inflammatory bowel disease
Scientific Title
Evaluation of intestinal mucosa in patients with inflammatory bowel disease
Scientific Title:Acronym
Evaluation of intestinal mucosa in patients with inflammatory bowel disease
Region
| Japan |
Condition
Condition
Inflamamatory bowel disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate the clinicopathologic characteristics of early postoperative UC-related enterocolitis/CD relapse by performing upper gastrointestinal endoscopy and lower endoscopy within 30 days before, during, 10-14 days after, 1 month after, and 3 months after surgery for IBD, along with other medical information.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For patients diagnosed with IBD and undergoing treatment at the hospital, biopsies are performed during upper and lower endoscopy to evaluate the intestinal mucosa (preoperative evaluation). For patients who undergo surgery during the course of treatment, biopsies of normal and ulcerated areas and stool samples are obtained from intraoperative endoscopic and intraoperative specimens (intraoperative evaluation). In addition, upper and/or lower gastrointestinal endoscopy is performed 10-14 days, 1 month, and 3 months postoperatively to evaluate the images and biopsy inflammation of the mucosa (postoperative evaluation).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients diagnosed with UC or CD and undergoing treatment at this hospital
2 Patients who have the capacity to consent and whose written consent can be obtained
3 Patients who are scheduled for surgical treatment or have already undergone surgical treatment
4 Patients with no history of UC or CD, diagnosed with colorectal cancer and scheduled for surgical treatment
Key exclusion criteria
1 Patients who did not give consent for this study
2 Patients deemed by the treating physician to be ineligible for enrollment in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Seishima |
Organization
Keio Univeristy School of Medicine
Division name
Department of Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
r.seishima@keio.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Seishima |
Organization
Keio Univeristy School of Medicine
Division name
Department of Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
r_seishima@ybb.ne.jp
Sponsor or person
Institute
Keio Univeristy
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Institutional Review Board of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2024 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063228
