[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539662":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequential screening group","EXPERIMENTAL","The enrolled participants will undergo a questionnaire investigation and receive a risk assessment for esophageal and gastric malignancies based on two questionnaire-based diagnostic models. Participants identified as \"high-risk\" (i.e., with a top 50% risk level) for esophageal and\u002For gastric malignancy will receive the standard upper gastrointestinal endoscopy. Standardized diagnosis and treatment recommendations will be provided to patients with screening-detected malignant lesions, and green referral channels will be established for them. For participants with screening-detected premalignant lesions, the risk of progression will be evaluated based on endoscopic characteristics, pathological diagnosis, and biomarkers. Individualized reexamination and surveillance will be implemented accordingly.",[13],"Procedure: Risk Assessment and Individualized Surveillance",{"label":15,"type":16,"description":17,"interventionNames":18},"Universal screening group","ACTIVE_COMPARATOR","The enrolled participants will undergo a questionnaire investigation and receive the same standard upper gastrointestinal endoscopy as those in the sequential screening group, irrespective of the results of the risk assessment. Standardized diagnosis and treatment recommendations will be provided to patients with screening-detected malignant lesions, and green referral channels will be established for them. For participants with screening-detected premalignant lesions, the reexamination and surveillance will be performed according to the current guidelines for UGIC screening and clinical treatment.",[19],"Procedure: Universal screening",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Risk Assessment and Individualized Surveillance","1. An epidemiological questionnaire-based risk assessment for UGIC conducted prior to the endoscopic examination;\n2. 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;\n3. 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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Universal screening","1. A questionnaire investigation;\n2. All participants undergo the upper gastrointestinal endoscopic examination with Lugol's Iodine in the esophagus and indigo carmine staining in the stomach;\n3. Reexamination and surveillance will be performed according to the current guidelines for UGIC screening and clinical treatment.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Zhonghu He","CONTACT","010-88196702","zhonghuhe@bjcancer.org",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Department of genetics, Peking University Cancer Hospital & Institute","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53,54],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":36},{"name":55,"role":56,"phone":26,"phoneExt":26,"email":26},"Zhonghu He, PhD","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100539662","effectiveness-of-risk-based-sequential-screening-for-esophageal-and-gastric-cancer-100539662",false,"NCT06306755","Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer","Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer: A Community-Based Randomized Controlled Trial","ERSS-EGC","Inclusion Criteria:\n\n* Permanent residency in the target villages in Xun County, Henan Province, China;\n* Aged 50 to 69 at the enrollment;\n* Voluntarily participate in this study and provide informed consent.\n\nExclusion Criteria:\n\n* Had a history of endoscopic examination within 5 years prior to the initial interview;\n* Had a history of cancer;\n* Had a history of mental disorder;\n* Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV);\n* Had severe cardiovascular and cerebrovascular diseases;\n* Had severe respiratory disease, dyspnea, or asthmaticus status;\n* Had retropharyngeal abscess, severe spinal deformity, or aortic aneurysm;\n* With physical debility unable to tolerate endoscopic examination, or with difficulty in achieving sedation and self-control;\n* In the acute phase of corrosive inflammation of the upper gastrointestinal tract, or with suspected perforation of the upper gastrointestinal tract;\n* Had massive ascites, severe abdominal distension, or severe esophageal varices;\n* Pregnancy;\n* Had severe history of allergies;\n* Had propensity for bleeding (coagulopathy);\n* Others unable to tolerate the clinical examinations involved in this study.",true,"ALL","50 Years","69 Years",{"count":72,"type":73},21000,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.\n\nA 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.\n\nIn 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.\n\nDetection 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.",[79,80,81,82,83],"Esophageal Cancer","Gastric Cancer","Precision Screening","Sequential Screening","Risk Stratification","2025-01-21",{"date":86,"type":87},"2025-01-24","ACTUAL",{"date":89,"type":87},"2024-06-25",{"date":91,"type":73},"2034-12",{"name":5,"class":6},1]