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.

Eligibility

Inclusion Criteria:

* Permanent residency in the target villages in Xun County, Henan Province, China;
* Aged 50 to 69 at the enrollment;
* Voluntarily participate in this study and provide informed consent.

Exclusion Criteria:

* Had a history of endoscopic examination within 5 years prior to the initial interview;
* Had a history of cancer;
* Had a history of mental disorder;
* Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV);
* Had severe cardiovascular and cerebrovascular diseases;
* Had severe respiratory disease, dyspnea, or asthmaticus status;
* Had retropharyngeal abscess, severe spinal deformity, or aortic aneurysm;
* With physical debility unable to tolerate endoscopic examination, or with difficulty in achieving sedation and self-control;
* In the acute phase of corrosive inflammation of the upper gastrointestinal tract, or with suspected perforation of the upper gastrointestinal tract;
* Had massive ascites, severe abdominal distension, or severe esophageal varices;
* Pregnancy;
* Had severe history of allergies;
* Had propensity for bleeding (coagulopathy);
* Others unable to tolerate the clinical examinations involved in this study.

Conditions6

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