UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040949 |
|---|---|
| Receipt number | R000046761 |
| Scientific Title | SNP analysis of Japanese achalasia patients |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2020/06/29 19:14:55 |
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Basic information
Public title
SNP analysis of Japanese achalasia patients
Acronym
SNP analysis of Japanese achalasia patients
Scientific Title
SNP analysis of Japanese achalasia patients
Scientific Title:Acronym
SNP analysis of Japanese achalasia patients
Region
| Japan |
Condition
Condition
Esophageal achalasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the bathogenesis of the Japanese esophageal achalasia
Basic objectives2
Others
Basic objectives -Others
To investigate difference of SNP among subtype of esophageal achalasia
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To analyze DNA genomic SNP related to Japanese esophageal achalasia
Key secondary outcomes
1) To evaluate differece of SNP among subtype of esophageal achalasia based on HRM
2) To evaluate differece of SNP among subtype of esophageal achalasia based on esophagogram.
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)male and female patients aged 20 years old or more
2)diagnosis as esophageal achalasia
3)undergoing HRM
Key exclusion criteria
1)Relatives within second degree of non-Japanese and Okinawan
2) Inappropriate patients judged by responsible person
Target sample size
1552
Research contact person
Name of lead principal investigator
| 1st name | Isomoto |
| Middle name | |
| Last name | Hajime |
Organization
Tottori Unversity
Division name
Department of Gastroenterology and Nephrology
Zip code
683-8504
Address
Nishicho, 36-1, Yonago
TEL
0859-38-6527
isomoto@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Ikebuchi |
| Middle name | |
| Last name | Yuichiro |
Organization
Tottori Unversity
Division name
Department of Gastroenterology and Nephrology
Zip code
683-8504
Address
Nishicho, 36-1, Yonago
TEL
0859-38-6527
Homepage URL
ikebu@tottori-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Nephrology, Tottori University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Nephrology, Tottori University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori-University
Address
Nishicho, 36-1, Yonago
Tel
0859-38-6527
isomoto@tottori-u.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
東京大学、昭和大学江東豊洲病院、福岡大学、新潟大学消化器内科、東北大学消化器外科
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On the basis of Chicago and Japanese classification
Management information
Registered date
| 2020 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046761
