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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042820
Receipt No. R000048883
Scientific Title Effects of alcohol metabolism gene activity and drinking on the occurrence of aty other time multiple gastric cancer after endoscopic resection of gastric cancer
Date of disclosure of the study information 2021/01/01
Last modified on 2021/06/26

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Basic information
Public title Effects of alcohol metabolism gene activity and drinking on the occurrence of aty other time multiple gastric cancer after endoscopic resection of gastric cancer
Acronym Effects of alcohol metabolism gene activity and drinking on the occurrence of aty other time multiple gastric cancer after endoscopic resection of gastric cancer
Scientific Title Effects of alcohol metabolism gene activity and drinking on the occurrence of aty other time multiple gastric cancer after endoscopic resection of gastric cancer
Scientific Title:Acronym Effects of alcohol metabolism gene activity and drinking on the occurrence of aty other time multiple gastric cancer after endoscopic resection of gastric cancer
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 In this study, we will verify that ALDH2 hypoactive and drinking alcohol are risk factors for the occurrence of atyor multiple gastric cancer after treatment in patients with gastric cancer endoscopic resection.
Basic objectives2 Others
Basic objectives -Others In this study, we will verify that ALDH2 hypoactive and drinking alcohol are risk factors for the occurrence of atyor multiple gastric cancer after treatment in patients with gastric cancer endoscopic resection.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of onset of atyptic gastric cancer after gastric cancer EMR/ESD by ADH1B/ALDH2 geno type
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Gene
Interventions/Control_1 About 0.5 ml of saliva is collected with a dropper before endoscopic surgery.
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) Saliva collection is possible
(2) Those who have received sufficient explanations in participating in this study, and have obtained the consent of the research subject's own free will after sufficient understanding.
(3) Gastric cancer EMR/ESD cases (first treatment cases / past cases)
(4) Histological gastric cancer has been diagnosed in resected specimens.
(5) It has been completely removed endoscopically.
Key exclusion criteria (1) Patients with added surgery
(2) Patients deemed unsuitable as subjects by the research manager
(3) Minors (under 20 years old)
(4) Pregnant patients

Target sample size 400

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Abiko
Organization Hakodate Municipal Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 041-8680
Address 10-1 1-Chome Minato-chou
TEL 0138432000
Email abiko1982@gmail.com

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Abiko
Organization Hakodate Municipal Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 041-8680
Address 10-1 1-Chome Minato-chou
TEL 0138432000
Homepage URL
Email abiko1982@gmail.com

Sponsor
Institute Hakodate Municipal Hospital
Institute
Department

Funding Source
Organization Kushiro Rosai Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hakodate Municipal Hospital
Address 10-1 1-Chome Minato-chou
Tel 0138432000
Email abiko1982@gmail.com

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
2021 Year 01 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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 12 Month 22 Day
Last modified on
2021 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048883

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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