UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032422 |
|---|---|
| Receipt number | R000036970 |
| Scientific Title | Use of intestinal ultrasound to predict short-term prognosis in inflammatory bowel disease |
| Date of disclosure of the study information | 2018/05/29 |
| Last modified on | 2021/07/21 23:27:28 |
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Basic information
Public title
Use of intestinal ultrasound to predict short-term prognosis in inflammatory bowel disease
Acronym
IBD and sonography: relationship with prognosis
Scientific Title
Use of intestinal ultrasound to predict short-term prognosis in inflammatory bowel disease
Scientific Title:Acronym
IBD and sonography: relationship with prognosis
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess value of bowel wall ultrasound in short-term clinical response evaluation in inflammatory bowel disease patients.
Basic objectives2
Others
Basic objectives -Others
Predictive value of bowel wall ultrasound for prognosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Association of initial ultrasound findings (0 and/or 1 week) findings and clinical remission rate at 8 weeks
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
The patients fulfilling all of the following criteria were subjected to the survey.
1. UC and CD patients who matched the diagnosis of specific disease investigation committee of Japanese ministry of health, labor and welfare and are patients in Kitasato University Kitasato Institute Hospital.
2. Patients of either gender
3. Patients who understood the purpose of experiment and signed a consent form.
Key exclusion criteria
1. When the patient does not agree to the experiment.
2. When the doctor determines that the survey is not medically or ethically adequate to the patient.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Sagami |
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 108-8642, Japan
TEL
03-3444-6161
sagami@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Sagami |
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 108-8642, Japan
TEL
03-3444-6161
Homepage URL
sagami@insti.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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Kitasato Institute Hospital
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
Tel
03-3444-6161
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
| 2018 | Year | 05 | Month | 29 | 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
| 2018 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment of target people: patients who receive standard care in Kitasato University Kitasato Institute Hospital between 29th May 2018 and 31th Mar. 2021.
Management information
Registered date
| 2018 | Year | 04 | Month | 28 | Day |
Last modified on
| 2021 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036970
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
