UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013363 |
|---|---|
| Receipt number | 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 18:25:56 |
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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
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
DRI2439@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College Hospital
second internal medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015516
