UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056773 |
|---|---|
| Receipt number | R000064889 |
| Scientific Title | Anti-integrin alphaVbeta6 antibody titer and the development of ulcerative colitis: a prospective multicenter study in Japan |
| Date of disclosure of the study information | 2025/01/23 |
| Last modified on | 2025/04/10 09:16:28 |
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Basic information
Public title
Anti-integrin alphaVbeta6 antibody titer and the development of ulcerative colitis: a prospective multicenter study in Japan
Acronym
Anti-integrin alphaVbeta6 antibody titer and ulcerative colitis in the Japanese prospective cohort
Scientific Title
Anti-integrin alphaVbeta6 antibody titer and the development of ulcerative colitis: a prospective multicenter study in Japan
Scientific Title:Acronym
Anti-integrin alphaVbeta6 antibody titer and ulcerative colitis in the Japanese prospective cohort
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the positive rate of anti-integrin alphaVbeta6 antibodies and their ability to predict the onset of ulcerative colitis in the general young Japanese population.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between anti-integrin alphaVbeta6 antibody and the development of ulcerative colitis
Key secondary outcomes
-Anti-integrin alphaVbeta6 antibody positive rate
-Association between anti-integrin alphaVbeta6 antibody and ulcerative colitis prevalence
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
Subjects who enroll in the faculties of universities or colleges related to research institutions from 2024 to 2028. The starting year for eligible students is the year in which ethics committee approval is obtained at each facility.
Key exclusion criteria
Subjects who do not consent to participate in the study.
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Tadakazu |
| Middle name | |
| Last name | Hisamatsu |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
thisamatsu@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Miyoshi |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
Homepage URL
jmiyoshi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Tadakazu Hisamatsu
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-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
札幌医科大学医学部消化器内科学（北海道）、東北大学医学部大学院医学系研究科消化器病態学分野（宮城県）、北里大学北里研究所病院（東京都）、杏林大学医学消化器内科学（東京都）、富山大学附属病院炎症腸疾患内科（富山県）、兵庫医科大学医学部消化器内科学講座（兵庫県）、佐賀大学医学部消化器内科（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 23 | 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
| 2024 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Anti-integrin alphaVbeta6 antibody was reported by a Japanese study group as an autoantibody with high sensitivity and specificity for ulcerative colitis. It has also been suggested in overseas cohorts that the antibody has the potential to predict the onset of ulcerative colitis. However, the positivity rate in the general young population in Japan and the ability to predict the onset of the disease through long-term follow-up remain unclear. Since the onset of ulcerative colitis is influenced by population distribution, genetic background, and environmental factors, the ability of anti-integrin alphaVbeta6 antibodies to predict the onset of ulcerative colitis may differ in Japan from other countries. Therefore, this study aims to investigate the positive rate of anti-integrin alphaVbeta6 antibodies and their ability to predict the development of ulcerative colitis in the general young Japanese population.
Management information
Registered date
| 2025 | Year | 01 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064889
