NCT06896370

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started Jul 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jul 2025Dec 2035

First Submitted

Initial submission to the registry

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2035

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

9.8 years

First QC Date

March 20, 2025

Last Update Submit

February 23, 2026

Conditions

Gastric (Stomach) CancerHelicobacter Infection

Outcome Measures

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).

    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.

    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.

    From enrollment to the end of the study in 10 years

Study Arms (3)

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

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.

Control 1Control 2exposure group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects were recruited from communities in Tongling, Anhui Province.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

People's Hospital of Tongling City

Tongling, China

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsHelicobacter Infections

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Dazhi Xu, PhD

CONTACT

86-18121299796xudzh@fudan.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 26, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

May 1, 2035

Study Completion (Estimated)

December 31, 2035

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

CN(1)