ClinicalTrials.gg
RecruitingNCT06896370Updated Feb 25, 2026

An Observational Study for Gastric Cancer in Carriers of High Risk Helicobacter Pylori

An observational study in Gastric (Stomach) Cancer and Helicobacter Infection, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
40 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 58 studies in Stomach Neoplasms by Fudan University — 27 open to participants now, 31 under way, 3 of them phase 3. Stomach Neoplasms · Fudan University.

Planned enrollment
4th of 10
3,000 · median 1,800
Started
2025
with 7 others
Observational
10 of 58
7 open now
Primary completion
2035-05
later than 30 of 30 live
Registered
44th of 58
by date

Among the 58 studies in Stomach Neoplasms by Fudan University, this one is the 4th largest by planned enrollment of the 10 observational ones that give a count, is one of 8 that started in 2025, is one of 10 observational ones, reaches primary completion later than 30 of the 30 other live ones, and was the 44th registered.

Stomach Neoplasms

3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

27 of the 58 studies in Stomach Neoplasms by Fudan University are open now, in 1 country. Recruiting first, the newest first:

21 more — sign in →

By country, each count listing its studies:

All 27 open studies →

Where they have run

Who these studies take

Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.

This study: 40 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 58 studies in Stomach Neoplasms by Fudan University, or all of them as a file.
02

Study 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 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.).

03

Conditions studied

  • Gastric (Stomach) Cancer
  • Helicobacter Infection
04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Subjects were recruited from communities in Tongling, Anhui Province.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 40 years, gender is not limited.
  2. Able and willing to provide and willing to undergo baseline and follow-up examinations.

Exclusion criteria

Exclusion Criteria:

  1. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
  2. Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short or render long-term follow-up impractical.
  3. Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
  4. Pregnant or breastfeeding women.
  5. Other conditions that the investigator deems inappropriate for participation in the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • exposure group

    HP positive with high-risk SNP subtypes

    Other: observational study

  • Control 1

    Hp positive + non-high risk SNP

    Other: observational study

  • Control 2

    Hp negative

    Other: observational study

Interventions

  • Otherobservational study

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: From enrollment to the end of the study in 3 years

Secondary outcomes

  1. 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).

    Time frame: From enrollment to the end of the study in 10 years

  2. 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.

    Time frame: From enrollment to the end of the study in 10 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for May 2035, 118 months after the start.

Of 323 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 171. This study's planned 118 months is above that.

Counting every sponsor, half of 365 studies reached it within 54 months; a quarter within 29 and three quarters within 119.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2025
First posted
Mar 26, 2025
StartActual
Jul 1, 2025
Primary completionEst.
May 1, 2035
CompletionEst.
Dec 31, 2035
Last update
Feb 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06896370
Lead sponsor
Fudan University
Responsible party
Dazhi Xu (Director, Fudan University) — Principal investigator
First posted
Mar 26, 2025
Start date
Jul 1, 2025
Primary completion
May 1, 2035 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
Feb 25, 2026

Study contacts

Dazhi Xu, PhD
Contact
xudzh@fudan.edu.cn
86-18121299796

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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