UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034576
Receipt No. R000039411
Scientific Title Exploratory clinical trials evaluating the usefulness of fecal calprotectin as a monitoring of Crohn's disease using MR enterography
Date of disclosure of the study information 2019/10/22
Last modified on 2018/10/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Exploratory clinical trials evaluating the usefulness of fecal calprotectin as a monitoring of Crohn's disease using MR enterography
Acronym Exploratory clinical trials evaluating the usefulness of fecal calprotectin as a monitoring of Crohn's disease using MR enterography
Scientific Title Exploratory clinical trials evaluating the usefulness of fecal calprotectin as a monitoring of Crohn's disease using MR enterography
Scientific Title:Acronym Exploratory clinical trials evaluating the usefulness of fecal calprotectin as a monitoring of Crohn's disease using MR enterography
Region
Japan

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

Objectives
Narrative objectives1 Evaluate the usefulness of fecal calprotectin as a monitoring of Crohn's disease using MR enterography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Fecal Calprotectin values
Key secondary outcomes Fecal Calprotectin values,
Crohn's disease clinical activity Index score, blood test every 2 months
Small bowel lesions with MRE at start

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are undergoing crohn's disease
Key exclusion criteria Patient who can not obtain written informed consent
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuka Fukuo
Organization Juntendo University Nerima Hospital
Division name Gastroenterology
Zip code
Address 3-1-10 Takanodai nerima-ku Tokyo
TEL 03-5923-3111
Email yfukuo@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Fukuo
Organization Juntendo University Nerima Hospital
Division name Gastroenterology
Zip code
Address 3-1-10 Takanodai nerima-ku Tokyo
TEL 03-5923-3111
Homepage URL
Email yfukuo@juntendo.ac.jp

Sponsor
Institute Juntendo University Nerima Hospital
Gastroenterology
Institute
Department

Funding Source
Organization TAIHO Phamaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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 順天堂大学医学部附属練馬病院

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 22 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 09 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observe for one year for Crohn's disease patients who visited our hospital. Study end date is August 31, 2022

Management information
Registered date
2018 Year 10 Month 19 Day
Last modified on
2018 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039411

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.