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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032872
Receipt No. R000037480
Official scientific title of the study Treat to target for Crohn's disease with portable bowel ultrasonography
Date of disclosure of the study information 2018/06/08
Last modified on 2018/06/05

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Basic information
Official scientific title of the study Treat to target for Crohn's disease with portable bowel ultrasonography
Title of the study (Brief title) Treat to target for Crohn's disease with portable bowel ultrasonography
Region
Japan

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

Objectives
Narrative objectives1 to evaluate the ulitity of portable bowel ultrasonography for CD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)cross sectional study: comparison between ultrasonography and BAE/MRI
2)cohort: relapse, hospitalization, surgery at 1 year
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria CD patients who undergo MRE/BAE
Key exclusion criteria patients who are difficult to obtain consent and contraindication for MRE/BAE
Target sample size 200

Research contact person
Name of lead principal investigator Kento Takenaka
Organization Tokyo Medical and Dental University
Division name gastroenterology and hepatology
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5877
Email kohtsuka.gast@tmd.ac.jp

Public contact
Name of contact person Kento Takenaka
Organization Tokyo Medical and Dental University
Division name Gastroenterology and Hepatology
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5877
Homepage URL
Email ktakenaka.gast@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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)

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 06 Month 08 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information ns

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037480

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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