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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041143
Receipt No. R000046965
Scientific Title 3D ultrasonography for intestinal fibrosis in Crohn's disease
Date of disclosure of the study information 2020/08/10
Last modified on 2020/07/16

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Basic information
Public title Can 3D ultrasonography evaluate fibrosis in Crohn's disease
Acronym 3D ultrasonography for Crohn's disease
Scientific Title 3D ultrasonography for intestinal fibrosis in Crohn's disease
Scientific Title:Acronym 3D ultrasonography for Crohn's disease
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Crohn's disease (CD) is an idiopathic, chronic entelitis with transmural inflammation that results in intestinal stricture. There are two types of stricture: inflammatory stricture caused by edema and fibrotic stricture caused by fibrosis. It is desirable to establish imaging studies. In the present study, we will investigate the association between ultrasonographic pamameters such as wall thickening, increased blood flow, tissue elasticity, and histopathological fingings (fibrosis, inflammation, edema), and immunological findings (angiogenesis, inflammatory cell infiltration, cytokines and growth factors).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Primary outcome is to evaluate the usefulness of 3D ultrasound parameters (wall thickening, blood flow, and elasticity) as a method to differentiate between inflammatory and fibrotic stenoses that occur in Crohn's disease.
Key secondary outcomes Secondary outcome is to explore the immunological abnormalities that cause fibrosis by monitoring the immune abnormalities that cause stenosis by ultrasound.

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with CD who undergo CD-related surgery or MR enterography
Key exclusion criteria 1. Lesions that did not undergo intestinal resection, such as strictureplasty
2. When the principal investigator considered not suitable.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Shintaro
Middle name Sagami
Last name Sagami
Organization Kitasato University Kitasato Institute Hospital
Division name Department of gastroenterology
Zip code 108-8642
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 Shintaro
Middle name Sagami
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
Email sagami@insti.kitasato-u.ac.jp

Sponsor
Institute Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization KAKEN: 20K16707
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 Research Ethics Committee, Kitasato University Kitasato Research Institute Hospital
Address 5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
Tel 03-3444-6161
Email 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
2020 Year 08 Month 10 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 10 Day
Last follow-up date
2024 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 Crohn's disease related-surgery or MR enterography in Kitasato University Kitasato Institute Hospital between 10th August 2018 and 31th Mar. 2024.

Management information
Registered date
2020 Year 07 Month 17 Day
Last modified on
2020 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046965

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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