UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034576 |
|---|---|
| Receipt number | 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 | 2023/05/30 23:02:57 |
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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 | Yuka |
| Middle name | |
| Last name | Fukuo |
Organization
Juntendo University Nerima Hospital
Division name
Gastroenterology
Zip code
1778521
Address
3-1-10 Takanodai nerima-ku Tokyo
TEL
03-5923-3111
yfukuo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Fukuo |
Organization
Juntendo University Nerima Hospital
Division name
Gastroenterology
Zip code
1778521
Address
3-1-10 Takanodai nerima-ku Tokyo
TEL
03-5923-3111
Homepage URL
yfukuo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
Gastroenterology
Institute
Department
Personal name
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
Juntendo Nerima Hospital
Address
Juntendo University Nerima Hospital Gastroenterology
Tel
0359233111
yfukuo@juntendo.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
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
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
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039411
