Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer

Summary

To evaluate the feasibility, applicability, effectiveness, and health-economic value of the risk-based sequential screening modality for esophageal and gastric cancers, the investigators aim to initiate a community-based randomized controlled trial in Xun County, Henan Province, which is a high-risk region of upper gastrointestinal cancer (UGIC) in northern China.

A total of 258 target villages from all the 11 communities (townships and streets) in Xun County will be randomly selected and assigned to the sequential screening group and the universal screening group at a ratio of 2:1 and the total sample size will be 21,000.

In the sequential screening group, participants in the top 50% risk level (i.e., stratified as the high-risk subgroup) will be offered a standard upper gastrointestinal endoscopic screening. In contrast, all participants in the universal screening group will receive the endoscopic examination. The surveillance strategy for participants with screening-detected premalignant lesions in the sequential screening group will be tailored based on individualized risk assessment using endoscopic characteristics, pathological diagnosis, and biomarkers. Surveillance for participants in the universal screening group will adhere to current guidelines for UGIC screening and clinical treatment.

Detection rates of upper gastrointestinal malignant lesions, early-stage malignant lesions and premalignant lesions, and health-economic indicators such as the unit cost per detected malignant lesions will be compared between the two groups.

Conditions

• Esophageal Cancer
• Gastric Cancer
• Precision Screening
• Sequential Screening
• Risk Stratification

Interventions

PROCEDURE

Risk Assessment and Individualized Surveillance

1. An epidemiological questionnaire-based risk assessment for UGIC conducted prior to the endoscopic examination; 2. Individuals identified as "high-risk" receive the upper gastrointestinal endoscopic examination with Lugol's Iodine in the esophagus and indigo carmine staining in the stomach; 3. Individualized reexamination and surveillance strategy will be given to participants diagnosed with premalignant lesions, based on evaluation of risk progression using endoscopic characteristics, pathological diagnosis, and biomarkers.

PROCEDURE

Universal screening

1. A questionnaire investigation; 2. All participants undergo the upper gastrointestinal endoscopic examination with Lugol's Iodine in the esophagus and indigo carmine staining in the stomach; 3. Reexamination and surveillance will be performed according to the current guidelines for UGIC screening and clinical treatment.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-25

Primary Completion

2028-12-31

Completion

2034-12-31

Countries

• China

Study Locations