UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049850 |
|---|---|
| Receipt number | R000056781 |
| Scientific Title | Analysis of inflammation and fibrosis mechanisms in eosinophilic esophagitis and esophageal motility disorders. |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/12/21 13:26:55 |
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Basic information
Public title
Analysis of inflammation and fibrosis mechanisms in eosinophilic esophagitis and esophageal motility disorders.
Acronym
Analysis of inflammation and fibrosis mechanisms in eosinophilic esophagitis and esophageal motility disorders.
Scientific Title
Analysis of inflammation and fibrosis mechanisms in eosinophilic esophagitis and esophageal motility disorders.
Scientific Title:Acronym
Analysis of inflammation and fibrosis mechanisms in eosinophilic esophagitis and esophageal motility disorders.
Region
| Japan |
Condition
Condition
Eosinophilic Esophagitis, Esophageal Achalasia, Esophageal Motility Disorder
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Elucidating the role of T cells in the induction of inflammation in eosinophilic esophagitis and esophageal motility disorders.
Basic objectives2
Others
Basic objectives -Others
To examine the impact of eosinophilic inflammation on the development of esophageal motility disorders.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of clinical information with the phenotype of T cells in tissues and blood in cases of eosinophilic esophagitis and esophageal motility disorders
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
1. Patients with eosinophilic esophagitis or esophageal motility disorders
2. Patients who are aged 20 years or older at the time of acquisition
3. Patients who agree to participate this study after receiving an explanation and providing consent forms
Key exclusion criteria
1. Patients who refused to participate in this study
2. Patients judged to be ineligible by the research director
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Kaneko |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171
Homepage URL
kanekota@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Research ethics committee of the graduate school of medicine, Chiba university
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-222-7171
inohana-rinri@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 01 | 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
| 2019 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to elucidate the pathogenesis underlying eosinophilic esophagitis and esophageal motility disorders.
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056781
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
