UMIN-CTR Clinical Trial

Basic information
Public title	Involvement of esophageal achalasia and achalasia-related diseases and viral infections and their regulators
Acronym	Involvement of esophageal achalasia and achalasia-related diseases and viral infections and their regulators
Scientific Title	Involvement of esophageal achalasia and achalasia-related diseases and viral infections and their regulators
Scientific Title:Acronym	Involvement of esophageal achalasia and achalasia-related diseases and viral infections and their regulators
Region	Japan

Condition
Condition	esophageal achalasia and achalasia-related diseases
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Patients undergoing POEM treatment for esophageal achalasia and achalasia-related diseases will be targeted, and patients with non-esophageal motor dysfunction such as esophageal cancer who will undergo esophagectomy will serve as a control group. Involvement of achalasia and virus infection, especially microRNA expression analysis of herpesvirus (HSV-1, HSV-2 etc.) and analysis of its regulatory molecule by collecting esophageal muscle layer sample of LES part and performing transcriptome analysis. I do.
Basic objectives2	Others
Basic objectives -Others	In addition, the specifically detected virus is confirmed to be localized by in situ hybridization. Serum is preserved in case a virus species that can be diagnosed by its serum antibody titer is identified. Through transcriptome analysis, we aim to elucidate the pathology by analyzing esophageal achalasia and viral infections and their regulatory molecules, focusing on the expression of various viruses including herpesvirus, especially viral microRNAs involved in latent infection and reactivation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quantitative analysis of herpesvirus microRNA expression in the esophageal muscle layer of patients with esophageal achalasia or achalasia-related disease. Transcriptome analysis of infectious virus species and their regulatory molecules in the esophageal muscle layer of patients with esophageal achalasia or achalasia-related diseases.
Key secondary outcomes	Relationship between esophageal achalasia (Type I, Type II, Type III) or patients with achalasia-related diseases and viral infection in the esophageal muscle layer and its regulatory molecules and various pathological conditions. Relationship between esophageal achalasia (Type I, Type II, Type III) or achalasia-related disease patients, identified virus species, and various pathological conditions. Serological diagnosis of viruses that can cause esophageal achalasia and other esophageal dyskinesia.

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients group: Showa University Koto Toyosu Hospital Gastroenterology Center, Fukuoka University Hospital, Tokyo Jikei University School of Medicine Hospital (1) Patients over 20 years old who undergo POEM treatment for esophageal achalasia and achalasia-related diseases (2) Patients who fully understand this research plan and can consent to it (3) Patients who are 20 years of age or older at the time of obtaining consent Control group: Tottori University Hospital (1) Patients with non-esophageal movement disorders such as esophageal cancer who undergo esophagectomy (2) Patients who fully understand this research plan and can consent to it (3) Patients who are 20 years of age or older at the time of obtaining consent
Key exclusion criteria	Patients group: (1) Patients who are judged to be ineligible to perform POEM (2) Patients who are judged to be inappropriate by the doctor in charge (for example, patients in a significantly bad condition) (3) Patients who cannot obtain informed consent Control group: Patients who cannot obtain informed consent
Target sample size	210

Research contact person
Name of lead principal investigator	1st name Haruhiro Middle name Last name Inoue
Organization	Showa University Koto Toyosu Hospital
Division name	Digestive Diseases Center
Zip code	1358577
Address	Tokyo-to, Koto-ku, Toyosu, 5-1-38
TEL	03-6204-6000
Email	haruinoue777@yahoo.co.jp

Public contact
Name of contact person	1st name Yuichiro Middle name Last name Ikebuchi
Organization	Tottori University Hospital
Division name	Gastroenterology
Zip code	6838504
Address	Tottori-ken, Yonago-shi, Nishi-machi 36-1
TEL	0859-38-6527
Homepage URL
Email	ikebu@tottori-u.ac.jp

Sponsor
Institute	Showa University Koto Toyosu Hospital
Institute
Department

Funding Source
Organization	Tottori University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Fukuoka University Hospital, Jikei University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa University Koto Toyosu Hospital
Address	Tokyo-to, Koto-ku, Toyosu, 5-1-38
Tel	03-6204-6000
Email	th_irb@ofc.showa-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

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2018 Year 04 Month 09 Day
Date of IRB	2018 Year 04 Month 09 Day
Anticipated trial start date	2021 Year 03 Month 31 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Currently, 80 cases are registered.

Management information
Registered date	2020 Year 05 Month 07 Day
Last modified on	2020 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046001

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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