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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028629
Receipt No. R000032767
Scientific Title Usefulness of Kyoto classification of gastritis in the diagnosis of H.pylori infection and the risk of gastric cancer.; Prospective study.
Date of disclosure of the study information 2017/09/01
Last modified on 2018/09/27

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Basic information
Public title Usefulness of Kyoto classification of gastritis in the diagnosis of H.pylori infection and the risk of gastric cancer.; Prospective study.
Acronym Usefulness of Endoscopic screening in the diagnosis of H.pylori infection and the risk of gastric cancer.
Scientific Title Usefulness of Kyoto classification of gastritis in the diagnosis of H.pylori infection and the risk of gastric cancer.; Prospective study.
Scientific Title:Acronym Usefulness of Endoscopic screening in the diagnosis of H.pylori infection and the risk of gastric cancer.
Region
Japan

Condition
Condition gastritis
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate usefulness of Kyoto classification of gastritis in the diagnosis of H.pylori infection and the risk of gastric cancer.
Basic objectives2 Others
Basic objectives -Others Usefulness
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. The correlation between ABC screening for gastric cancer and score of Kyoto classification.
2. The cumulative incidence rate using ABC screening for gastric cancer and score of Kyoto classification until 10 years later.
Key secondary outcomes 1. Sensitivity and specificity of regular arrangement of collecting venules(RAC) in the diagnosis of H.pylori infection.
2. Usefulness in the diagnosis of H.pylori infection using score of Kyoto classification.
3. The proportion and characteristics of false A group in ABC screening.
4. The proportion and characteristics of gastric cancer using score of ABC screening and Kyoto classification until 10 years later.
5. The proportion and characteristics of gastric cancer in A group of ABC score.
6. The proper surveilance interval depending on the status of H.pylori infection.

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
Device,equipment
Interventions/Control_1 ABC screening, Esophagogastroduodenoscopy
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. 20y.o<
2. Those who underwent Esophagogastroduodenoscopy screening in our institution.
3. Written informed consent.
Key exclusion criteria 1. Pregnant
2. Others
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Shimodate
Organization Kurashiki Central Hospital
Division name Department of gastroenterology
Zip code
Address 1-1-1, Miwa, Kurashiki, Okayama.
TEL 086-422-0210
Email ys13544@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mami Kobayashi
Organization Kurashiki Central Hospital
Division name Department of gastroenterology
Zip code
Address 1-1-1, Miwa, Kurashiki, Okayama.
TEL 086-422-0210
Homepage URL
Email ys13544@kchnet.or.jp

Sponsor
Institute Kurashiki Central Hospital
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 09 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 Completed
Date of protocol fixation
2017 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 10 Day
Last modified on
2018 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032767

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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