UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040845 |
|---|---|
| Receipt number | R000046634 |
| Scientific Title | Clinicopathological study on eosinophilic esophagitis |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2021/08/05 15:10:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinicopathological study on eosinophilic esophagitis
Acronym
Clinicopathological study on EoE
Scientific Title
Clinicopathological study on eosinophilic esophagitis
Scientific Title:Acronym
Clinicopathological study on EoE
Region
| Japan |
Condition
Condition
eosinophilic esophagitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the endoscopic characteristics, pathological findings, and clinical features of eosinophilic esophagitis.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between endoscopic findings and pathological findings and clinical features.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the pathological findings and clinical features associated with the endoscopic findings 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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with suspected EoE and undergoing endoscopy
Key exclusion criteria
Patients who did not consent to the study or who were considered unfit by the physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Manabe |
Organization
Kawasaki Medical School
Division name
Division of endoscopy and Ultrasonography
Zip code
700-8505
Address
2-6-1, Nakasange, Kita-ku
TEL
086-225-2111
n_manabe@hkg.odn.ne.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Manabe |
Organization
Kawasaki Medical School
Division name
Division of endoscopy and Ultrasonography
Zip code
700-8505
Address
2-6-1, Nakasange, Kita-ku
TEL
086-225-2111
Homepage URL
n_manabe@hkg.odn.ne.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama
Tel
086-462-1111
kmsrec@med.kawasaki-m.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
川崎医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | 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
| 2020 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data will be collected and examined for endoscopic findings, histological findings, and clinical features.
Management information
Registered date
| 2020 | Year | 06 | Month | 21 | Day |
Last modified on
| 2021 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046634
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
