[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613420":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":46,"centralContacts":50,"locations":55,"responsibleParty":71,"collaborators":10,"id":73,"slug":10,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":10,"enrollmentInfo":83,"targetDuration":10,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8,14,18,22,25,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Discovery cohort (ESCC)",null,"Patients with ESCC",[13],"Diagnostic Test: Small RNA sequencing of exo- and cf-miRNAs",{"label":15,"type":10,"description":16,"interventionNames":17},"Discovery cohort (NDC)","Non-Disease Control",[13],{"label":19,"type":10,"description":11,"interventionNames":20},"Training cohort (ESCC)",[21],"Diagnostic Test: PCR-based validation (SYNERGY assay)",{"label":23,"type":10,"description":16,"interventionNames":24},"Training cohort (NDC)",[21],{"label":26,"type":10,"description":11,"interventionNames":27},"Testing cohort (ESCC)",[28],"Diagnostic Test: RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)",{"label":30,"type":10,"description":16,"interventionNames":31},"Testing cohort (NDC)",[28],[33,38,42],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"DIAGNOSTIC_TEST","Small RNA sequencing of exo- and cf-miRNAs","Identification of differentially expressed cf-miRNAs",[9,15],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"RT-qPCR quantification of cf- and exo-miRNAs (SYNERGY assay)","RT-qPCR quantification of cf- and exo-miRNAs, and construction of machine learning classifier",[26,30],{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"PCR-based validation (SYNERGY assay)","PCR-based validation of the SYNERGY miRNA panel",[19,23],[47],{"name":48,"affiliation":5,"role":49},"Ajay Goel, PhD","PRINCIPAL_INVESTIGATOR",[51],{"name":48,"role":52,"phone":53,"phoneExt":10,"email":54},"CONTACT","626-218-3452","ajgoel@coh.org",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Monrovia","California","91016","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-117.99895,34.14806,{"lat":67,"lon":66},[70],{"name":48,"role":52,"phone":53,"phoneExt":10,"email":54},{"type":72,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100613420",false,"NCT07266363","Integrated Cf-miRNA and Exosomal miRNA Signature for Early Detection of Esophageal Squamous Cell Carcinoma","SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma","SYNERGY","Inclusion Criteria:\n\n* Adults age 18 to 90 years\n* Histologically confirmed esophageal squamous cell carcinoma\n* No prior systemic therapy before sample collection\n* For control groups: absence of malignant disease\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Inadequate sample volume or RNA quality\n* Prior cancer within 5 years (except localized cancers)\n* Active systemic inflammation that may alter circulating RNA profiles",true,"ALL","18 Years",{"count":84,"type":85},600,"ESTIMATED","OBSERVATIONAL","Esophageal squamous cell carcinoma (ESCC) remains a highly lethal cancer worldwide, largely due to late diagnosis. Current screening methods such as upper endoscopy are invasive, operator-dependent, and limited in their ability to detect early-stage lesions.\n\nTo address this clinical need, the SYNERGY study seeks to develop a non-invasive, blood-based biomarker assay that integrates cell-free microRNAs (cf-miRNAs) and exosomal microRNAs (exo-miRNAs) to detect ESCC at an early and potentially curable stage.\n\nThis multicenter translational study includes discovery, training, and validation phases using preoperative plasma or serum samples. By combining the tumor specificity of exosomal miRNAs with the systemic sensitivity of cf-miRNAs, SYNERGY aims to construct a robust diagnostic model with high sensitivity and specificity for early ESCC detection.",[89],"ESCC",[91,92,93,94],"Exosomal miRNAs","Cell-free miRNAs","Esophageal squamous cell carcinoma","Liquid biopsy","2025-12-03",{"date":97,"type":98},"2025-12-05","ACTUAL",{"date":100,"type":98},"2025-01-15",{"date":102,"type":85},"2026-06-18",{"name":5,"class":6},1]