[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575445":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":23,"locations":10,"responsibleParty":29,"collaborators":10,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":10,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":10,"enrollmentInfo":40,"targetDuration":43,"studyType":44,"phases":10,"briefSummary":45,"conditions":46,"keywords":48,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":10},{"fullName":5,"class":6},"Fuzhou General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients diagnosed with advanced stage NSCLC by pathology",null,"The study was conducted in 25 centers across the country, recruiting 200 patients with advanced NSCLC with different confirmed EGFR mutation types (Del-19, L858R, T790M, and no gene mutation).",[13],"Diagnostic Test: SERS sensor based on CHA reaction",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","SERS sensor based on CHA reaction","1\\. Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures. 2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. 3. The following is the general sequence of events during the 3 months evaluation period: 4. Completion of baseline procedures Participants were assessed for 3 months and completed all safety monitoring.",[9],[21,22],"NGS","RT-PCR",[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Zongyang Yu, Ph.D","CONTACT","13509327806","yuzy527@sina.com",{"type":30,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100575445","sers-sensor-based-on-cha-reaction-for-egfr-mutation-typing-in-advanced-lung-cancer-100575445",false,"NCT06772376","SERS Sensor Based on CHA Reaction for EGFR Mutation Typing in Advanced Lung Cancer","SERS Sensor Based on CHA Reaction for EGFR Mutation Typing in Advanced Lung Cancer: A Multicenter, Open-Label, Double-Blind, Independent Data Analysis Clinical Trial","Inclusion Criteria:\n\n1. Participants with Lung cancer meeting the criteria of TNM (Ninth Edition);\n2. Participants are willing to participate in this study and follow the research plan;\n3. Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website;\n\nExclusion Criteria:\n\n1. Patients with other active malignant tumors;\n2. Patients with missing baseline clinical data;\n3. Patients with severe underlying lung diseases (such as bronchiectasis, bronchial asthma or COPD, etc.), or those with a history of occupational or environmental exposure to dust, mines or asbestos;\n4. Participants who do not cooperate or refuse to participate in clinical trials at a later stage.","ALL","18 Years",{"count":41,"type":42},400,"ESTIMATED","1 Year","OBSERVATIONAL","Summary:This study is a prospective, multicenter clinical study. In previous studies, we successfully constructed a CHA reaction-mediated self-calibrated SERS biosensor for the detection of EGFR mutation typing (Del-19, T790M, L858R) in lung cancer patients, and verified that the accuracy, sensitivity, and specificity of the SERS biosensor exceeded 95% in a small sample of 32 patients. In order to obtain the highest level of clinical evidence and truly achieve clinical transformation, this prospective, multicenter clinical study aims to verify the analytical efficiency of the SERS biosensor for EGFR mutation typing in patients with advanced lung cancer.\n\nPurpose：This prospective, multicenter clinical study aims to verify the analytical efficacy of the previously constructed CHA reaction-mediated self-calibrated SERS biosensor in EGFR mutation typing in patients with advanced lung cancer.\n\nResearch subjects: The patients enrolled in this project are confirmed to be advanced non-small cell lung cancer (NSCLC). Enrollment will be completed in 25 centers and the enrollment will be competitive.\n\nResearch location: 900th Hospital of Joint Logistics Support Force Research intervention: None Study duration: Patients will be enrolled from June 2024 to June 2025. Subject participation time: Telephone follow-up will be conducted every three months until the end of the study.",[47],"Lung Cancer in Normal and Malignant Tumors",[49,50,51,52],"SERS","CHA","EGFR","advanced lung cancer","NOT_YET_RECRUITING","2025-03-26",{"date":56,"type":57},"2025-03-31","ACTUAL",{"date":59,"type":42},"2026-05-01",{"date":61,"type":42},"2026-06-01",{"name":5,"class":6}]