protocolSection identificationModule nctId: NCT06306755, orgStudyIdInfo id: 2021YFC2500405, briefTitle: Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer, acronym: ERSS-EGC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2034-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Peking University Cancer Hospital & Institute, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Esophageal Cancer, conditions: Gastric Cancer, conditions: Precision Screening, conditions: Sequential Screening, conditions: Risk Stratification, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 21000, type: ESTIMATED, armsInterventionsModule interventions name: Risk Assessment and Individualized Surveillance, interventions name: Universal screening, outcomesModule primaryOutcomes measure: Detection rate of upper gastrointestinal (esophageal/gastric) malignant lesions, secondaryOutcomes measure: Rate of early-stage upper gastrointestinal (esophageal/gastric) malignant lesions, secondaryOutcomes measure: Detection rate of upper gastrointestinal (esophageal/gastric) premalignant lesions, secondaryOutcomes measure: Response rate of endoscopic examination, secondaryOutcomes measure: Total screening costs, secondaryOutcomes measure: Unit cost per detected upper gastrointestinal (esophageal/gastric) malignant lesions, secondaryOutcomes measure: Unit cost per detected early-stage upper gastrointestinal (esophageal/gastric) malignant lesions, secondaryOutcomes measure: Unit cost per detected upper gastrointestinal (esophageal/gastric) premalignant lesions, secondaryOutcomes measure: Satisfaction with the risk-based sequential screening modality, secondaryOutcomes measure: Rate of timely treatment, secondaryOutcomes measure: UGIC-specific mortality, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Quality of life Scale Score, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of genetics, Peking University Cancer Hospital & Institute, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Zhonghu He, role: CONTACT, email: zhonghuhe@bjcancer.org, contacts name: Zhonghu He, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False