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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040949
Receipt No. 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

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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
Email 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
Email ikebu@tottori-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Nephrology, Tottori University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046761

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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