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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name