UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042820 |
|---|---|
| Receipt number | 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 | 2023/07/01 19:24:48 |
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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
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
abiko1982@gmail.com
Sponsor or person
Institute
Hakodate Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Kushiro Rosai Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
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
Main results already published
Date of protocol fixation
| 2020 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 01 | Day |
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
| 2023 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048883
