UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic features in patient with early gastric cancer detected after successful Helicobacter pylori eradication
Title of the study (Brief title)	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	Yuji Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Gastroenterology and Hepatology
Address	465 Kajiicho Kamigyoku Kyoto
TEL	075-251-5111
Email	ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person	Atsushi Majima
Organization	Kyoto Prefectural University of Medicine
Division name	Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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