UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049488 |
|---|---|
| Receipt number | R000056338 |
| Scientific Title | A multi-center observational study for validation to establish severity criteria for intestinal Behcet's disease. |
| Date of disclosure of the study information | 2022/11/14 |
| Last modified on | 2025/05/16 17:32:32 |
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Basic information
Public title
A multi-center observational study for validation to establish severity criteria for intestinal Behcet's disease.
Acronym
Multi-center observational study to establish severity criteria for intestinal Behcet's disease.
Scientific Title
A multi-center observational study for validation to establish severity criteria for intestinal Behcet's disease.
Scientific Title:Acronym
Multi-center observational study to establish severity criteria for intestinal Behcet's disease.
Region
| Japan |
Condition
Condition
intestinal Behcet's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intestinal Behcet's disease is defined as one of the peculiar types (special lesions), associated with intestinal lesions, among patients diagnosed with Behcet's disease. Although the severity criteria for Behcet's disease already exist, this classification cannot determine a treatment policy according to the severity of intestinal Behcet's disease, and it is required to create severity criteria limited to intestinal Behcet's disease.
The purpose of this study is to establish the severity criteria for intestinal Behcet's disease in Japan and to verify the validity of the criteria we created at multiple institutions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between severity assessment and subsequent hospitalization or surgery rate in patients with intestinal Behcet's disease.
Key secondary outcomes
1) Relationship between severity at diagnosis and Disease Activity Index for Intestinal BD (DAIBD).
2) Relationship between severity at assessment and serological severity.
3) The relationship between the severity at the time of judgment and the treatment newly added within 1 month and 3 months after the judgment at the time of severity judgment.
4) Treatment responsiveness when therapeutic intervention is performed in 3).
5) Relationship between severity at time of diagnosis and time to hospitalization after diagnosis.
6) Relationship between the severity at the time of judgment and the period until surgery is required after judgment.
7) Relationship between severity at judgment and clinical background other than the above.
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
Patients diagnosed by the Ministry of Health, Labor and Welfare research group Behcet's disease diagnostic criteria or clinically diagnosed as (intestinal) Behcet's disease and patients with simple ulcers.
Key exclusion criteria
1) Patients who are judged to be inappropriate as subjects by the judgment of researchers.
2) Those who refused to participate in this study.
3) Atypical cases without ileo-cecal lesions.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Naganuma |
Organization
Kansai Medical University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata City, Osaka Prefecture
TEL
072-804-0101
naganuma@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Fukui |
Organization
Kansai Medical University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata City, Osaka Prefecture
TEL
072-804-0101
Homepage URL
https://www.kmu.ac.jp/hirakata/hospital/2671t800000135zj.html
fukuitos@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyorin University Hospital
Keio University Hospital
Tokyo Medical and Dental University Hospital
Shiga University of Medical Science Hospital
Hyogo College of Medicine Hospital
Fukuoka University Hospital
Toho University Medical Center Sakura Hospital
Iwate Medical University Hospital
Other participating institutions
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Ethics Review Center
Address
2-5-1 Shinmachi, Hirakata City, Osaka Prefecture
Tel
072-804-0101
rinriirb@hirakata.kmu.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
関西医科大学附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.kmu.ac.jp/hirakata/hospital/2671t800000135zj.html
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
154
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
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Severity created by the intestinal Behcet's disease severity creation project and existing clinical severity, serological severity (CRP, ESR, hemoglobin level, albumin), treatment content (at the time of severity assessment, within 1 month after assessment) and newly added treatment and dosage within 3 months), presence or absence of hospitalization (presence or absence of hospitalization at the time of severity determination, presence or absence of hospitalization by intestinal Behcet after severity determination, and period from severity determination to hospitalization), Presence or absence of surgery (presence or absence of surgery by intestinal Behcet after severity determination and period from severity determination to surgery).
Management information
Registered date
| 2022 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056338
