NCT06853509

Predicting Gastric Neoplasia in Patients with High-risk Endoscopic Features

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,700 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Gastric Neoplasia

Interventions

Type	Name	Description
OTHER	No Intervention: Observational Cohort	No Intervention: Observational Cohort

Timeline

• Start date: 2025-03-01
• Primary completion: 2033-12-31
• Completion: 2033-12-31
• First posted: 2025-03-03
• Last updated: 2025-03-03

Locations

1 site across 1 country: China