Helicobacter PyloriNCT00596401
The Preventive Effect of Helicobacter Pylori Eradication on the Development of Gastric Cancer
An observational study of Helicobacter Pylori and Eradication, run by Showa Inan General Hospital at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori, Eradication, Gastric Cancer
- How many people
- 3,000 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2007to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who live in Iijima town
Who may be able to join
- People who live in Iijima town at their age of 19 to 69 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Helicobacter Pylori Eradication on the Development of Gastric Cancer and the Medical Care Cost in Iijima Town
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.
- Conditions
- Helicobacter Pylori, Eradication, Gastric Cancer, Medical Care Cost
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | HP eradication group | |
| 2 | No eradication group | |
| 3 | No Hp group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the annual incidence of gastric cancer in Iijima town
Measured: 10 years
Secondary outcomes (1)
The annual medical care cost in Iijima town
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startSep 2007
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa Inan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Horiuchi, Showa Inan General Hospital
- Investigators
- Akira Horiuchi, M.D., Study director, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596401
- Sponsor's protocol ID
- sihp20076
- Status last verified
- Feb 2022
- First submitted
- 8 Jan 2008
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Helicobacter Pylori Eradication on the Development of Gastric Cancer and the Medical Care Cost in Iijima Town
- ClinicalTrials.gov ID
- NCT00596401
- Acronym / sponsor ID
- sihp20076
- Conditions
- Helicobacter Pylori, Eradication, Gastric Cancer, Medical Care Cost
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –HP eradication group |
| 2 | – | –No eradication group |
| 3 | – | –No Hp group |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who live in Iijima town
Key inclusion criteria (1 listed)
- People who live in Iijima town at their age of 19 to 69 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the annual incidence of gastric cancer in Iijima town
Time frame: 10 years
1 secondary outcome
The annual medical care cost in Iijima town
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akira Horiuchi, M.D. study director
Showa Inan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori and Eradication, run by Showa Inan General Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the annual incidence of gastric cancer in Iijima town (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.