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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013363
Receipt No. R000015516
Scientific Title Utility of fecal calprotectin in patients with Crohn's disease
Date of disclosure of the study information 2014/03/31
Last modified on 2014/02/28

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Basic information
Public title Utility of fecal calprotectin in patients with Crohn's disease
Acronym Utility of fecal calprotectin in CD patients
Scientific Title Utility of fecal calprotectin in patients with Crohn's disease
Scientific Title:Acronym Utility of fecal calprotectin in CD patients
Region
Japan

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

Objectives
Narrative objectives1 evaluation of disease activity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes correlation with disease activity
Key secondary outcomes sensitivity to detect the active lesions

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 with Crohn's disease were underwent all of blood, fecal, total colonoscopy and MRI test.
Key exclusion criteria The duration of each examinations is more than two weeks.
The therapy changed during each examinations.
Disease activity changed during each examinations.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryota Hokari
Organization National Defense Medical College Hospital
Division name second internal medicine
Zip code
Address namiki 3-2 tokorozawa-city saitama
TEL 04-2995-1511
Email ryota@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Sato
Organization National Defense Medical College Hospital
Division name second internal medicine
Zip code
Address namiki 3-2 tokorozawa-city saitama
TEL 04-2995-1511
Homepage URL
Email DRI2439@ndmc.ac.jp

Sponsor
Institute National Defense Medical College Hospital
second internal medicine
Institute
Department

Funding Source
Organization National Defense Medical College
Organization
Division
Category of Funding Organization
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 防衛医科大学校病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 31 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 Completed
Date of protocol fixation
2012 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 11 Day
Last follow-up date
2013 Year 05 Month 30 Day
Date of closure to data entry
2013 Year 10 Month 26 Day
Date trial data considered complete
2014 Year 01 Month 12 Day
Date analysis concluded
2014 Year 02 Month 10 Day

Other
Other related information This study is pospective study and we picked up subjects by case control.

Management information
Registered date
2014 Year 03 Month 06 Day
Last modified on
2014 Year 02 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015516

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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