UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022242 |
|---|---|
| Receipt number | R000025627 |
| Scientific Title | Role of epidermal differentiation complex (EDC) protein in eosinophilic esophagitis |
| Date of disclosure of the study information | 2016/05/10 |
| Last modified on | 2016/05/12 11:56:53 |
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Basic information
Public title
Role of epidermal differentiation complex (EDC) protein in eosinophilic esophagitis
Acronym
Role of epidermal differentiation complex (EDC) protein in eosinophilic esophagitis
Scientific Title
Role of epidermal differentiation complex (EDC) protein in eosinophilic esophagitis
Scientific Title:Acronym
Role of epidermal differentiation complex (EDC) protein in eosinophilic esophagitis
Region
| Japan |
Condition
Condition
eosinophilic esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the role of EDC protein in eosinophilic esophagitis
Basic objectives2
Others
Basic objectives -Others
To help the diagnosis of eosinophilic esophagitis using immunostaining of EDC protein
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The expression of EDC protein in eosinophlic esophagitis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinically diagnosised with eosinophilic esophagitis, which is defined as the presence of more than 15 eosinophiles per HPF discovered in biopsy samples taken with endoscopy
Key exclusion criteria
patients who are not eligible for participation judged by a doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University Faculty of Medicine
Division name
2nd department of Internal Medicine
Zip code
Address
89-1, Enya-cho, Izumo, Shimane
TEL
0853-20-2190
kinosita@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Oshima |
Organization
Shimane University Faculty of Medicine
Division name
2nd department of Internal Medicine
Zip code
Address
89-1, Enya-cho, Izumo, Shimane
TEL
0853-20-2190
Homepage URL
n-oshima@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine, 2nd department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine, 2nd department of Internal Medicine
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Patients and tissue collection: Patients had histologically confirmed esophageal epithelial eosinophilic infiltration greater than 15 per high-power field in examinations performed since 2005, and satisfied the diagnostic criteria according to guidelines current at the time of examination
Management information
Registered date
| 2016 | Year | 05 | Month | 09 | Day |
Last modified on
| 2016 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025627
