Background: The effectiveness of current early screening strategies for gastric precancerous lesions remains limited. Early identification and risk-stratified management of precancerous conditions are critical to prevent or delay malignant transformation. Although several studies have focused on developing gastric cancer risk prediction models, most were derived from selected cohorts with limited real-world validation. As a result, the clinical utility, scalability, and corresponding management strategies remain uncertain. Robust real-world evidence is therefore needed to evaluate the effectiveness and implementation potential of comprehensive risk stratification models, as well as optimal intervention strategies.
Objectives: This study aims to externally validate an established risk prediction model for gastric precancerous lesions and to develop a real-world risk-stratified management. It also seeks to assess the clinical value of adjunctive traditional Chinese medicine (TCM) therapies across different risk strata, focusing on both short-term symptom relief and long-term progression risk, to guide risk-based management strategies.
Methods: This real-world study will recruit more than 8,100 participants who will complete standardized questionnaires and provide baseline data. Participants will be stratified into high and low risk groups using the previously developed prediction model for gastric precancerous lesions, followed by endoscopic examination in both groups. Model performance will be evaluated using discrimination, calibration, sensitivity, specificity, and non-inferiority compared with endoscopic detection. Participants diagnosed with precancerous lesions will receive risk-stratified management, including adjunctive TCM interventions as determined in routine care. The effects of interventions on disease progression will be assessed using a target trial emulation framework during longitudinal endoscopic follow-up.
Results: This is a real-world study protocal. Ethical approval for this study has been obtained from the Ethics Committee of the National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences (reference number: 26/009-5734). During the preliminary phase of study implementation, baseline epidemiological and clinical data from approximately 100 participants have been collected, including demographic characteristics, endoscopic examination history, outpatient visits, clinical symptoms, and pathological findings. Data collection for the full cohort is currently underway, with completion anticipated by 2027. Final analyses will be conducted after completion of follow-up according to the predefined protocol.
Implications: This study will generate real-world evidence on the performance and clinical applicability of a screening and management model for gastric precancerous lesions and early cancer prevention. By integrating risk stratification with longitudinal follow-up and target trial emulation analyses, the findings are expected to inform the development of scalable, risk-adapted prevention and intervention strategies, and to support evidence-based decision-making for gastric cancer prevention.

Technology roadmap