Gastric (Stomach) CancerNCT06896370
An Observational Study for Gastric Cancer in Carriers of High Risk Helicobacter Pylori
An observational study of Gastric (Stomach) Cancer and Helicobacter Infection, run by Fudan University at 1 site in China.
Trial summary
This study is intended to be a prospective observational cohort study. The incidence of gastric cancer and progression of gastric precancerous lesions will be compared between groups through prospective follow-up of a population with baseline negative gastric endoscopy, harboring high-risk Hp SNP subtypes and… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric (Stomach) Cancer, Helicobacter Infection
- What is being tested?
- observational study
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2035
- Phase
- Observational
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects were recruited from communities in Tongling, Anhui Province.
Who may be able to join
- Age ≥ 40 years, gender is not limited.
- Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.
Who cannot join
- A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
- Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
- Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
- Pregnant or breastfeeding women.
- Other conditions that the investigator deems inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
People's Hospital of Tongling City
Tongling
Guihe Wang, 86-05625838104, 2175613200@qq.com
About this study
Official title: Risk of Gastric Cancer in High-risk Carriers of Helicobacter Pylori: an Observational Cohort Study
This study is intended to be a prospective observational cohort study. The incidence of gastric cancer and progression of gastric precancerous lesions will be compared between groups through prospective follow-up of a population with baseline negative gastric endoscopy, harboring high-risk Hp SNP subtypes and non-high-risk subtypes.
Read the detailed description
Primary study objective: to assess the difference in the incidence of gastric cancer between carriers of high-risk SNP subtypes of H. pylori and the non-high-risk population during the follow-up period.
Secondary research objectives: 1. To observe and compare the cumulative incidence and progression of gastric precancerous lesions (e.g., atrophic gastritis, intestinal metaplasia, etc.) in each population group during the follow-up period.2. To explore the interaction of high-risk SNPs on the risk of gastric cancer in the context of different age, gender or other risk factors (e.g. diet, smoking, alcohol abuse, family history, etc.).
- Conditions
- Gastric (Stomach) Cancer, Helicobacter Infection
- Being tested
- observational study
- Medical subject headings
- Stomach Neoplasms, Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
By prospectively following a population of asymptomatic carriers carrying high-risk Hp SNP subtypes and non-high-risk subtypes, the incidence of gastric cancer and progression of gastric precancerous lesions were compared between the groups.
| Study group | Role | What they receive |
|---|---|---|
| exposure group | HP positive with high-risk SNP subtypes Receives: Other: observational study | |
| Control 1 | Hp positive + non-high risk SNP Receives: Other: observational study | |
| Control 2 | Hp negative Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) during a 3-year follow-up.
Evaluate the difference in the incidence of gastric cancer between high-risk and non-high-risk groups, while considering the comparison with the HP negative group. The comparison between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) will assess the difference in gastric cancer incidence during a 3-year follow-up. Gastric cancer incidence will be determined based on pathological confirmation (biopsy results).
Measured: From enrollment to the end of the study in 3 years
Secondary outcomes (2)
Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) at 5-, and 10-year follow-up time points.
Evaluate the difference in the incidence of gastric cancer between high-risk and non-high-risk groups, while considering the comparison with the HP negative group. The comparison between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) will assess the difference in gastric cancer incidence at 5-, and 10-year follow-up time points. Gastric cancer incidence will be determined based on pathological confirmation (biopsy results).
Measured: From enrollment to the end of the study in 10 years
Differences in the incidence of gastric precancerous lesions among three groups (Hp-positive high-risk, Hp-positive non-high-risk, and Hp-negative) at 3-, 5-, and 10-year follow-up time points.
Evaluate the difference in the incidence of precancerous lesions between high-risk and non-high-risk groups at 3-, 5-, and 10-year follow-up time points, while considering the HP negative group. This comparison will also help assess the effect of HP infection on the development of precancerous lesions.
Measured: From enrollment to the end of the study in 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Jul 2025
- Primary completion1 May 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric (Stomach) CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896370
- Sponsor's protocol ID
- 2025 observational study
- Status last verified
- Feb 2026
- First submitted
- 20 Mar 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Gastric Cancer in High-risk Carriers of Helicobacter Pylori: an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06896370
- Acronym / sponsor ID
- 2025 observational study
- Conditions
- Gastric (Stomach) Cancer, Helicobacter Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 May 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 26 Mar 2025 (actual)
- 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.
This study is intended to be a prospective observational cohort study. The incidence of gastric cancer and progression of gastric precancerous lesions will be compared between groups through prospective follow-up of a population with baseline negative gastric endoscopy, harboring high-risk Hp SNP subtypes and non-high-risk subtypes.
Detailed description
Primary study objective: to assess the difference in the incidence of gastric cancer between carriers of high-risk SNP subtypes of H. pylori and the non-high-risk population during the follow-up period.
Secondary research objectives: 1. To observe and compare the cumulative incidence and progression of gastric precancerous lesions (e.g., atrophic gastritis, intestinal metaplasia, etc.) in each population group during the follow-up period.2. To explore the interaction of high-risk SNPs on the risk of gastric cancer in the context of different age, gender or other risk factors (e.g. diet, smoking, alcohol abuse, family history, etc.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exposure group | – | Other: observational studyHP positive with high-risk SNP subtypes |
| Control 1 | – | Other: observational studyHp positive + non-high risk SNP |
| Control 2 | – | Other: observational studyHp negative |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were recruited from communities in Tongling, Anhui Province.
Key inclusion criteria (2 listed)
- Age ≥ 40 years, gender is not limited.
- Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.
Key exclusion criteria (5 listed)
- A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
- Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
- Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
- Pregnant or breastfeeding women.
- Other conditions that the investigator deems inappropriate for participation in the study.
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 |
|---|---|---|
| observational studyBy prospectively following a population of asymptomatic carriers carrying high-risk Hp SNP subtypes and non-high-risk subtypes, the incidence of gastric cancer and progression of gastric precancerous lesions were compared between the groups. | Other | Control 1, Control 2, exposure group |
Primary outcome
Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) during a 3-year follow-up.
Time frame: From enrollment to the end of the study in 3 years
Evaluate the difference in the incidence of gastric cancer between high-risk and non-high-risk groups, while considering the comparison with the HP negative group. The comparison between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) will assess the difference in gastric cancer incidence during a 3-year follow-up. Gastric cancer incidence will be determined based on pathological confirmation (biopsy results).
2 secondary outcomes
Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) at 5-, and 10-year follow-up time points.
Time frame: From enrollment to the end of the study in 10 years
Differences in the incidence of gastric precancerous lesions among three groups (Hp-positive high-risk, Hp-positive non-high-risk, and Hp-negative) at 3-, 5-, and 10-year follow-up time points.
Time frame: From enrollment to the end of the study in 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 25 Feb 2026.
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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.
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 Gastric (Stomach) Cancer and Helicobacter Infection, run by Fudan University 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. 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. 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?
Contact Dazhi Xu, PhD (86-18121299796, xudzh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) during a 3-year follow-up. (time frame: From enrollment to the end of the study in 3 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 25 Feb 2026.