Predicting Gastric Neoplasia in Patients with High-risk Endoscopic Features

NCT06853509 | Not Yet Recruiting

• 1 other identifier: 2024K339-F251
• Study Type: observational
• Target: 2,700
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gastric Neoplasia

Outcome Measures

Primary Outcomes (1)

• Detection rate of gastric neoplasia

  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

Study Arms (1)

High-risk endoscopic features

Patients found active Helicobacter pylori infection or atrophic gastritis in initial esophagogastroduodenoscopy.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No Intervention: Observational Cohort

High-risk endoscopic features

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with high-risk endoscopic features

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong hospital affiliated to Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

Central Study Contacts

Danian Ji, M.D.

CONTACT

+86-18019094606; arctg4@163.com

Zhiyu Dong, M.D.

CONTACT

+86-18817870866; 18817870866@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: March 3, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after completion of this study
• Access Criteria: All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)

Locations

CN (1)