UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between anti-helicobacter pylori antibody, pepsinogen and gastric cancer
Title of the study (Brief title)	Relationship between Hp antibody, PG and gastric cancer
Region	Japan

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

Objectives
Narrative objectives1	To clarify the relationship between the gastric cancer causing rate and gastric atrophy or H.pylori infection in five years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gastric cancer causing rate in five years of each groups
Key secondary outcomes	Rate of past history of gastric cancer. Cause specific death rate of gastric cancer.

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 of the patients who have a check-up in Saku central hospital by gastroscopy from June 2010 to May 2011, and agree with 5 year's follow up.
Key exclusion criteria	The patients who have past history of total gastrectomy.
Target sample size	10000

Research contact person
Name of lead principal investigator	OYAMA TSUNEO
Organization	SAKU CENTRAL HOSPITAL ADVANCED CARE CENTER
Division name	GASTROENTEROLOGY
Address	3400-28 NAKAGOMI, SAKU, NAGANO
TEL	0267-62-8181
Email	oyama@coral.ocn.ne.jp

Public contact
Name of contact person	MIYUKI NIIMI
Organization	SAKU CENTRAL HOSPITAL
Division name	Clinical Research Center
Address	3400-28 NAKAGOMI, SAKU, NAGANO
TEL	0267-62-8181
Homepage URL
Email	ctroffice@sakuhp.or.jp

Sponsor
Institute	SAKU CENTRAL HOSPITAL ADVANCED CARE CENTER
Institute
Department

Funding Source
Organization	None
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	佐久総合病院佐久医療センター

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 05 Month 10 Day
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date	2016 Year 05 Month 01 Day
Date of closure to data entry	2016 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	The patients who have a check-up in Saku central hospital will be examined by gastroscopy to identify gastric cancer.

Management information
Registered date	2010 Year 05 Month 31 Day
Last modified on	2017 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004453