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NCT Number: NCT07438418

An Observational Study on Gastric Cancer in High-risk Individuals

This study is designed as a prospective observational cohort study, aiming to assess the differences in the occurrence of gastric cancer and the progression of gastric cancer-related precancerous lesions between individuals who test positive or negative for fecal multi-target testing, with baseline negative gastric endoscopy results. The clinical outcomes between the two groups will be compared through long-term follow-up.

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Key information

Conditions

Gastric Adenocarcinoma

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Primary study objective: to compare the differences in gastric cancer incidence between the two groups (individuals who are positive and negative for baseline fecal multi-target testing).

Secondary study objective: to compare the differences in gastric precancerous lesions incidence between the two groups (individuals who are positive and negative for baseline fecal multi-target testing).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

The result of fecal multi-target DNA testing

Diagnostic Test

By prospectively following individuals who are positive and negative for fecal multi-target testing with baseline negative gastric endoscopy, the incidence of gastric cancer and the progression of gastric precancerous lesions were compared between the two groups.

Primary outcomes

  1. Difference in the incidence of gastric cancer during a 3-year follow-up

    Time frame: During the initial 3-year period of the study

    To compare the difference in the incidence of gastric cancer between groups with positive and negative baseline fecal multi-target testing during a 3-year follow-up.

Secondary outcomes

  1. Difference in the incidence of gastric cancer at 5-, and 10-year follow-up time points

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

    To compare the difference in the incidence of gastric cancer between groups with positive and negative baseline fecal multi-target testing at 5-, and 10-year follow-up time points.

  2. Difference in the incidence of precancerous lesions associated with gastric cancer at 3-, 5-, and 10-year follow-up time points

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

    To compare the difference in the incidence of precancerous lesions associated with gastric cancer between groups with positive and negative baseline fecal multi-target testing at 3-, 5-, and 10-year follow-up time points.

Study contacts

Contact information is provided by the study sponsor or research team.

Dazhi Xu, PhD

CONTACT

[email protected]

86-18121299796

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Risk of Gastric Cancer in High-risk Individuals: an Observational Cohort Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2035
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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