UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The characteristics of gastric cancer detected after successful H.pylori eradication
Title of the study (Brief title)	The characteristics of gastric cancer detected after successful H.pylori eradication
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The clinicopathological characteristics of gastric cancer detected after successful H.pylori eradication were investigated.
Basic objectives2	Others
Basic objectives -Others	The primary outcomes between patients with active H.pylori infection and H.pylori eradicated were compared.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Age, sex, location of tumor, diameter of tumor, histological type of tumor, macroscopic type of tumor, the degree of background mucosal atrophy, the period from successful eradication to detection of gastric cancer (for eradicated patients only), and the reason of eradication (for eradicated patients only) in each patient
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All the patients who underwent endoscopic resection of gastric cancer at Kyoto Prefectural University of Medicine, between January 2009 and June 2014
Key exclusion criteria	The cases that were not examined for H. pylori infection
Target sample size	900

Research contact person
Name of lead principal investigator	Yuji Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Gastroenterology and Hepatology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto
TEL	075-251-5519
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 Kajii-cho, Kamigyo-ku, Kyoto
TEL	075-251-5519
Homepage URL
Email	a-majima@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
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	2016 Year 11 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 27 Day
Anticipated trial start date	2015 Year 10 Month 27 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	Retrospective study

Management information
Registered date	2016 Year 11 Month 22 Day
Last modified on	2016 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028698