[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598324":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":10,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":58,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Shanghai Chest Hospital of Shanghai Jiao Tong University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).",null,"Partial Response (PR): Defined as a reduction in the sum of the diameters of target lesions by ≥30% from baseline, in the absence of new lesions. This indicates effective treatment with significant tumor shrinkage.\n\nStable Disease (SD): Defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (i.e., the sum of the diameters of target lesions shows a change ranging from a decrease of \\\u003C30% to an increase of \\\u003C20%), in the absence of new lesions. This indicates that the disease has not worsened, but a significant reduction in tumor burden has not been achieved.\n\nProgressive Disease (PD): Defined as an increase in the sum of the diameters of target lesions by ≥20% (taking as reference the smallest sum on study), and\u002For the appearance of one or more new lesions. This signifies treatment failure, necessitating a modification of the therapeutic regimen.",[13],"Combination Product: EC\u002FEP + ICIs",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"COMBINATION_PRODUCT","EC\u002FEP + ICIs","Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Wei Zhang, MD","CONTACT","+86-021-62821990","zhwei2002@sjtu.edu.cn",[27],{"facility":28,"status":29,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Shanghai Chest Hospital","RECRUITING","Shanghai","200030","China","CN",{"type":35,"coordinates":36},"Point",[37,38],121.45806,31.22222,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Wei Zhang","Chief Physician","100598324","small-extracellular-vesicle-mirnas-as-predictive-biomarkers-for-immunochemotherapy-efficacy-in-extensive-stage-small-cell-lung-cancer-100598324",false,"NCT07070011","Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer","Inclusion Criteria:\n\nRequirements for patients enrolled in the project:\n\n1. The pathological diagnosis of the patient is ESSCLC;\n2. ECOG score 0 or 1；\n3. The patient is receiving immunotherapy combined with chemotherapy for the first time and has no history of chemotherapy treatment;\n4. Patients with complete clinical sample information who meet the inclusion requirements\n\nExclusion Criteria:\n\n1. Patients whose pathological diagnosis does not meet the requirements;\n2. Patients whose ECOG staging does not meet the requirements;\n3. Patients with a history of chemotherapy, immunotherapy, or immunotherapy combined with chemotherapy;\n4. Patients with incomplete clinical sample information and follow-up information;","ALL","45 Years","80 Years",{"count":56,"type":57},38,"ESTIMATED","38 Days","OBSERVATIONAL","This study aims to investigate the clinical value of small extracellular vesicle (sEV) miRNAs as predictive biomarkers for immunochemotherapy efficacy in extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC represents a highly aggressive neuroendocrine malignancy, where the current standard first-line treatment combining immune checkpoint inhibitors with chemotherapy lacks predictive biomarkers for individualized therapeutic strategies.\n\nA prospective observational cohort will be established at Shanghai Chest Hospital, enrolling treatment-naïve ES-SCLC patients. Distinct miRNA signatures differentiating responders from non-responders will be identified through pretreatment serum sEV miRNA sequencing and differential expression analysis. These findings may provide novel liquid biopsy biomarkers to guide personalized treatment strategies and optimize clinical decision-making in ES-SCLC management.",[62],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)",[64,65,66,67],"small cell lung cancer","immunochemotherapy","sEV miRNAs","predictive biomarkers","2025-07-16",{"date":70,"type":71},"2025-07-17","ACTUAL",{"date":73,"type":71},"2023-01-03",{"date":75,"type":57},"2026-12-31",{"name":5,"class":6},1]