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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032422
Receipt No. 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 2019/05/06

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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 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shintaro Sagami
Organization Kitasato University Kitasato Institute Hospital
Division name Center for Advanced IBD Research and Treatment
Zip code
Address 5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL 03-3444-6161
Email sagami@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shintaro Sagami
Organization Kitasato University Kitasato Institute Hospital
Division name Center for Advanced IBD Research and Treatment
Zip code
Address 5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL 03-3444-6161
Homepage URL
Email sagami@insti.kitasato-u.ac.jp

Sponsor
Institute Kitasato University Kitasato Institute Hospital
Institute
Department

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
Address
Tel
Email

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
2020 Year 03 Month 31 Day
Date of closure to data entry
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. 2020.

Management information
Registered date
2018 Year 04 Month 28 Day
Last modified on
2019 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036970

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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