The Preventive Effect of Helicobacter Pylori Eradication... | NCT00596401

Studies
The Preventive Effect of Helicobacter Pylori Eradication on the Development of Gastric Cancer

NCT00596401

Sponsor

Showa Inan General Hospital

Status

Completed

Last Update Posted

Feb 21, 2022Actual

Enrollment

3,000Actual

Phase

Not provided

Conditions

Helicobacter Pylori
Eradication
Gastric Cancer
Medical Care Cost

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Jan 8, 2008

First Submission Date that Met QC Criteria

Jan 16, 2008

First Posted Date

Jan 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2022

Last Update Posted Date

Feb 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Recently, the preventive effect of Helicobacter pylori (Hp) eradication treatment on the incidence of gastric cancer has been reported. By Hp eradication treatment being performed for Hp-infected people in Iijima town, we will evaluate whether the incidence of gastric cancer and/or the medical care cost can be reduced as compared with those in the previous years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		HP eradication group
2		No eradication group
3		No Hp group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the annual incidence of gastric cancer in Iijima town		10 years

Secondary Outcomes

Measure	Description	Time Frame
The annual medical care cost in Iijima town		10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People who live in Iijima town at their age of 19 to 69 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

People who live in Iijima town

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Akira Horiuchi, M.D.	Showa Inan General Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Showa Inan General hospital		Komagane	Nagano	399-4191	Japan

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided