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NCT Number: NCT06853509

Predicting Gastric Neoplasia in Patients with High-risk Endoscopic Features

A prospective, single-center, cohort study to development and validation of a prediction model for predicting gastric neoplasia in patients with high-risk endoscopic features

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Key information

Conditions

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huadong hospital affiliated to Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location contact

Danian Ji, M.D.

CONTACT

[email protected]

+86-18019094606

About this study

  • Patients at high risk for gastric cancer are undergone screening esophagogastroduodenoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
  • For every enrolled patient, follow-up esophagogastroduodenoscopy were conducted in the 3rd and 5th years after the baseline examination. If high-risk endoscopic features for gastric cancer (i.e., active Helicobacter pylori infection or atrophic gastritis classified as C2-O3 according to the Kimura-Takemoto classification) were observed during the baseline examination, an additional follow-up esophagogastroduodenoscopy was performed in the 1st year after the baseline examination.
  • Clinical characteristics, gastric neoplasia-related blood biomarkers, the extent of atrophic gastritis and other endoscopic findings were collected in baseline and follow-up esophagogastroduodenoscopy. For patients whose baseline esophagogastroduodenoscopy indicates open-type atrophic gastritis (Kimura-Takemoto classification O1-O3), blood samples will be collected for whole-genome sequencing at the time of the baseline and the final follow-up examination.
  • Enrolled patients were followed up until gastric neoplasia was detected, up to a maximum of 5 years.
  • After the study was completed, a prediction model for predicting gastric neoplasia in patients with atrophic gastritis was developed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 45 years
  • Meets the definition of a high-risk population for gastric cancer, which includes one or more of the following: (1) Residence in a high-incidence region for gastric cancer (2) Helicobacter pylori (Hp) infection (3) History of chronic atrophic gastritis, gastric ulcer, gastric polyps, post-gastrectomy status, hypertrophic gastritis, pernicious anemia, or other precancerous gastric conditions (4) First-degree relatives of patients with gastric cancer (5) Other risk factors for gastric cancer such as high salt intake, frequent consumption of pickled foods, smoking, or heavy alcohol use
  • No gastric cancer or precancerous lesions detected on initial esophagogastroduodenoscopy, yet with endoscopic features consistent with high-risk endoscopic features. High-risk endoscopic include: (1) Active Helicobacter pylori infection (2) Atrophic gastritis (Kimura-Takemoto classification C1-O3)
  • Provision of written informed consent and agreement to comply with the follow-up requirements specified in the study protocol

Exclusion criteria

  • Emergency esophagogastroduodenoscopy
  • History of partial or total gastrectomy
  • ASA physical status classification of 3 or higher
  • Use of oral antiplatelet or anticoagulant medications, or coagulopathy (defined as a platelet count < 50 × 10^9/L or INR > 1.5)
  • Pregnancy or lactation
  • Severe cardiac, pulmonary, hepatic, or renal disease
  • Concomitant other malignant tumors or severe infectious diseases
  • Refusal to sign the informed consent form or any other condition deemed unsuitable for study participation

Treatment and study plan

No Intervention: Observational Cohort

Other

No Intervention: Observational Cohort

Primary outcomes

  1. Detection rate of gastric neoplasia

    Time frame: 2 weeks after the last follow-up

    Detection rate of gastric neoplasia during follow-up. Gastric neoplasia was defined as low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and adenocarcinoma.

Study contacts

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

Danian Ji, M.D.

CONTACT

[email protected]

+86-18019094606

Zhiyu Dong, M.D.

CONTACT

[email protected]

+86-18817870866

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Development and Validation of a Prediction Model for Predicting Gastric Neoplasia in Patients with High-risk Endoscopic Features: a Prospective Cohort Study

Important dates

Study start
2025
Primary completion
2033
Study completion
2033
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

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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