UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota
Acronym	Relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota
Scientific Title	Relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota
Scientific Title:Acronym	Relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota
Region	Japan

Condition
Condition	Esophageal squamous cell carcinoma and achalasia
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to elucidate the relationship between carcinogenesis of esophageal squamous cell carcinoma and esophageal microbiota in patients with achalasia and esophageal squamous cell carcinoma.
Basic objectives2	Others
Basic objectives -Others	Esophageal microbiota before and after per-oral endoscopic myotomy in patients with achalasia.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The effect of esophageal microbiota on carcinogenesis of esophageal squamous cell carcinoma in patients with achalasia
Key secondary outcomes	Esophageal microbiota before and after per-oral endoscopic myotomy in patients with achalasia. Comparison of esophageal microbiota between the patients with esophageal squamous cell carcinoma and the patients with achalasia

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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	1. The patient who is older than 18 when the informed consent is obtained. 2. The patient who is diagnosed with achalasia or esophageal squamous cell carcinoma and is going to undergo endoscopic treatment in our hospital. 3. The performance status of the patients is 0, 1, or 2. 4. The patient whose informed consent is obtained.
Key exclusion criteria	1. The patient who is pregnant or performing breast feeding. 2. The patient who was registered in this study before. 3. The patient who has risks for bleeding after esophageal biopsy. 4. The patient who underwent gastrectomy before. 5. The patient who had past histories of cervical cancer or esophageal cancer treated by radiation. 6. The patient who are being treated for cancers in other organs 7. The patients who are judged by the investigators to be inappropriate participants in the trial.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shuji Terai
Organization	Graduate School of Medical and Dental Sciences, Niigata University
Division name	Division of Gastroenterology and Hepatology
Zip code
Address	757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL	025-227-2207
Email	terais@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuya Takahashi
Organization	Graduate School of Medical and Dental Sciences, Niigata University
Division name	Division of Gastroenterology and Hepatology
Zip code
Address	757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL	025-227-2207
Homepage URL
Email	kazuya911@med.niigata-u.ac.jp

Sponsor
Institute	Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	新潟大学医歯学総合病院

Other administrative information
Date of disclosure of the study information	2018 Year 07 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	Completed
Date of protocol fixation	2018 Year 06 Month 30 Day
Date of IRB	2018 Year 06 Month 18 Day
Anticipated trial start date	2018 Year 07 Month 30 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

In this study, we obtain esophageal specimens using a brush for biliary cytology via endoscopic forceps channel. we are going to perform 16S rRNA gene amplicon sequencing analysis in 5 patients with esophageal squamous cell carcinoma before endoscopic submucosal dissection and 15 patients with achalasia before and after per-oral endoscopic myotomy. We also investigate the relationship between inflammation of the esophageal epithelium and esophageal microbiota in these patients.

Management information
Registered date	2018 Year 07 Month 27 Day
Last modified on	2020 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038250