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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030538
Receipt No. R000034865
Scientific Title Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication
Date of disclosure of the study information 2017/12/25
Last modified on 2017/12/24

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Basic information
Public title Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication
Acronym Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication
Scientific Title Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication
Scientific Title:Acronym Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication
Region
Japan

Condition
Condition Gastric cancer detected after successful Helicobacter pylori eradication
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication.
Basic objectives2 Others
Basic objectives -Others To clarify endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The frequency of endoscopic finding recognized in patients with early gastric cancer detected after successful H.pylori eradication
Key secondary outcomes

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent esophagogastroduodenoscopy after successful H.pylori eradication at Kyoto Prefectural University of Medicine from November 2015
Key exclusion criteria Patients who underwent esophagogastroduodenoscopy within one year after H.pylori eradication
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Kamigyoku Kyoto
TEL 075-251-5111
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Majima
Organization Kyoto Prefectural University of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Kamigyoku Kyoto
TEL 075-251-5111
Homepage URL
Email a-majima@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Self funding
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 12 Month 25 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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 11 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 The frequency of endoscopic finding recognized in patients with early gastric cancer detected after successful H.pylori eradication

Management information
Registered date
2017 Year 12 Month 24 Day
Last modified on
2017 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034865

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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