UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026845 |
|---|---|
| Receipt number | R000030809 |
| Scientific Title | Metabolic analysis of eosinophilic esophagitis |
| Date of disclosure of the study information | 2017/04/05 |
| Last modified on | 2017/04/03 16:46:22 |
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Basic information
Public title
Metabolic analysis of eosinophilic esophagitis
Acronym
Metabolic analysis of eosinophilic esophagitis
Scientific Title
Metabolic analysis of eosinophilic esophagitis
Scientific Title:Acronym
Metabolic analysis of eosinophilic esophagitis
Region
| Japan |
Condition
Condition
Eosinophilic esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate characteristic serum metabolite of eosinophilic esophagitis using metabolic analysis
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metabolic analysis of serum taken from patients of eosinophilic 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eosinophilic esophagitis (EoE)
1. Patients who suffer from dysphagia and have 15 or more eosinophils/HPF in esophageal epithelium
2. Patients who provide writen informed consent
3. Patients 18 years or older
Non EoE
1. Subjects without dysphagia and characteristic endoscopic findings of EoE
2. Subjects who provide writen informed consent
3. Subjects 18 years or older
Key exclusion criteria
EoE/Non EOE
1. Sujects who have severe comorbidity
2. Subjects who have history of gastrointestinal surgery except for endoscopic treatment such as polypectomy and ESD
3. Subjects 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 | Yasuhiro Fujiwara |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3 Asahimachi, Abenoku, Osaka 545-8585
TEL
06-6645-3811
yasu@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinari Sawada |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku,Osaka 545- 8585, Japan
TEL
06-6645-3811
Homepage URL
m1164972@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 04 | Month | 05 | 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
| 2017 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing in particular
Management information
Registered date
| 2017 | Year | 04 | Month | 03 | Day |
Last modified on
| 2017 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030809
