Predicting Gastric Neoplasia in Patients with High-risk Endoscopic Features

February 28, 2025 updated by: Zhijun Bao, Fudan University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  2. 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.
  3. 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.
  4. Enrolled patients were followed up until gastric neoplasia was detected, up to a maximum of 5 years.
  5. After the study was completed, a prediction model for predicting gastric neoplasia in patients with atrophic gastritis was developed.

Study Type

Observational

Enrollment (Estimated)

2700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Danian Ji, M.D.
  • Phone Number: +86-18019094606
  • Email: arctg4@163.com

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huadong Hospital Affiliated to Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Individuals with high-risk endoscopic features

Description

Inclusion Criteria:

  1. Age ≥ 45 years
  2. 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
  3. 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)
  4. Provision of written informed consent and agreement to comply with the follow-up requirements specified in the study protocol

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High-risk endoscopic features
Patients found active Helicobacter pylori infection or atrophic gastritis in initial esophagogastroduodenoscopy.
Other: No Intervention: Observational Cohort
No Intervention: Observational Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks after the last follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

February 9, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024K339-F251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

IPD Sharing Time Frame

1 year after completion of this study

IPD Sharing Access Criteria

All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Neoplasia

Clinical Trials on No Intervention: Observational Cohort

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe