Helicobacter InfectionsNCT01133951
Helicobacter Pylori Eradication to Prevent Gastric Cancer
A study testing OAC triple therapy in people with Helicobacter Infections and Stomach Neoplasms, run by Jie-Jun Wang at 1 site in China.
Trial summary
Gastric cancer is the fourth most common type of cancer and the second leading cause of cancer-related death in the world. In China, more than 390,000 new patients are diagnosed with gastric cancer and more than 300,000 patients are killed by the terrible disease annually. Read more about this study
- Who is it for?
- Ages 30 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Infections, Stomach Neoplasms
- What is being tested?
- OAC triple therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to May 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy registered inhabitants from 10 villages in a high-risk county of gastric cancer in China
- Age 30-59 years
- A willingness to participate in the study as indicated by written informed consent
Who cannot join
- Severe concomitant illness (eg, severe hypertension, coronary heart disease, diabetes mellitus, stroke, asthma, liver cirrhosis, tuberculosis, infectious hepatitis, and cardiac, respiratory, hepatic, or renal insufficiency)
- Patients with epilepsy or severe mental illness
- Previous diagnosis of cancer
- A history of esophageal or gastric surgery
- Drug abuse and drug dependence
- Allergic to omeprazole, amoxicillin, or clarithromycin
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- Pregnant and lactating women
- Previous history of H pylori eradication treatment
- A negative 13C-urea breath test (UBT)
- A definite indication of H. pylori eradication (eg, gastric or duodenum ulcer)
- Dysplasia or carcinoma lesions are found in esophageal or gastric histopathological examination
- Other factors or conditions might influence the results of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial
Gastric cancer is the fourth most common type of cancer and the second leading cause of cancer-related death in the world. In China, more than 390,000 new patients are diagnosed with gastric cancer and more than 300,000 patients are killed by the terrible disease annually. Although gastric cancer has a multifactorial etiology, infection with H. pylori is highly associated with gastric carcinogenesis. Therefore, eradication of H. pylori infection appears to reduce the risk of gastric cancer. However, several recent controlled interventional trials by H. pylori eradication to prevent gastric cancer have yielded disappointing results. The exact effect of H.pylori eradication on prevention of gastric cancer is unclear up to now. To clarify this problem, the investigators conducted a prospective, randomized, double-blind, placebo-controlled, population-based study to determine whether H pylori eradication would reduce the incidence of gastric cancer in a high-risk population in China.
- Conditions
- Helicobacter Infections, Stomach Neoplasms
- Being tested
- OAC triple therapy, Placebo
- Keywords
- Helicobacter Infections, Helicobacter pylori, Drug Therapy, Precancerous Conditions, Stomach Neoplasms, Incidence
- Medical subject headings
- Helicobacter Infections, Stomach Neoplasms, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OAC triple therapyDrug
Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.
PlaceboDrug
Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| OAC triple therapy | Experimental | Not described Receives: Drug: OAC triple therapy |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric cancer incidence
The incidence of gastric cancer in the two groups
Measured: 10 years
Secondary outcomes (1)
Histopathological changes
The histopathological changes of atrophic gastritis or intestinal metaplasia in the two groups
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 posted31 May 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2012
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jie-Jun Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie-Jun Wang, Second Military Medical University
- Investigators
- Jie J Wang, M.D., Study chair, Shanghai Changzheng Hospital affiliated to Second Military Medical UniversityXi Wang, M.D., Principal investigator, Shanghai Changzheng Hospital affiliated to Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133951
- Sponsor's protocol ID
- SMMU20100501
- Status last verified
- Oct 2023
- First submitted
- 28 May 2010
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Eradication to Prevent Gastric Cancer in a High-Risk Population of China: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01133951
- Acronym / sponsor ID
- SMMU20100501
- Conditions
- Helicobacter Infections, Stomach Neoplasms
- Keywords
- Helicobacter Infections, Helicobacter pylori, Drug Therapy, Precancerous Conditions, Stomach Neoplasms, Incidence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Jie-Jun WangUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2032 (estimated)
- First posted
- 31 May 2010 (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.
Gastric cancer is the fourth most common type of cancer and the second leading cause of cancer-related death in the world. In China, more than 390,000 new patients are diagnosed with gastric cancer and more than 300,000 patients are killed by the terrible disease annually. Although gastric cancer has a multifactorial etiology, infection with H. pylori is highly associated with gastric carcinogenesis. Therefore, eradication of H. pylori infection appears to reduce the risk of gastric cancer. However, several recent controlled interventional trials by H. pylori eradication to prevent gastric cancer have yielded disappointing results. The exact effect of H.pylori eradication on prevention of gastric cancer is unclear up to now. To clarify this problem, the investigators conducted a prospective, randomized, double-blind, placebo-controlled, population-based study to determine whether H pylori eradication would reduce the incidence of gastric cancer in a high-risk population in China.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OAC triple therapy | Experimental | Drug: OAC triple therapy |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy registered inhabitants from 10 villages in a high-risk county of gastric cancer in China
- Age 30-59 years
- A willingness to participate in the study as indicated by written informed consent
Key exclusion criteria (12 listed)
- Severe concomitant illness (eg, severe hypertension, coronary heart disease, diabetes mellitus, stroke, asthma, liver cirrhosis, tuberculosis, infectious hepatitis, and cardiac, respiratory, hepatic, or renal insufficiency)
- Patients with epilepsy or severe mental illness
- Previous diagnosis of cancer
- A history of esophageal or gastric surgery
- Drug abuse and drug dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OAC triple therapyOmeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks. | Drug | OAC triple therapy |
| PlaceboOmeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks. | Drug | Placebo |
Primary outcome
Gastric cancer incidence
Time frame: 10 years
The incidence of gastric cancer in the two groups
1 secondary outcome
Histopathological changes
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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.
Jie J Wang, M.D. study chair
Shanghai Changzheng Hospital affiliated to Second Military Medical University
Xi Wang, M.D. principal investigator
Shanghai Changzheng Hospital affiliated to Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OAC triple therapy in people with Helicobacter Infections and Stomach Neoplasms, run by Jie-Jun Wang at 1 site in China.
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 3 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 10 Oct 2023. 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 China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Gastric cancer incidence (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 10 Oct 2023.