[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610225":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":45,"centralContacts":49,"locations":54,"responsibleParty":71,"collaborators":10,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":10,"enrollmentInfo":83,"targetDuration":10,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8,14,18,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Discovery Cohort - PFS ≥ 12 Months (Responder)",null,"Patients with mCRC who achieved progression-free survival ≥ 12 months after first-line chemotherapy (FOLFOX or FOLFIRI).\n\ncfDNA 5mC\u002F5hmC sequencing performed to identify epigenetic determinants of durable response.",[13],"Diagnostic Test: cfDNA 5mC\u002F5hmC Sequencing (EpiCORE Discovery Phase)",{"label":15,"type":10,"description":16,"interventionNames":17},"Discovery Cohort - PFS \u003C 12 Months (Non-Responder)","Patients with progression-free survival \\\u003C 12 months after first-line chemotherapy.\n\nCompared with responders to identify epigenetic features associated with resistance.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Training Cohort - PFS ≥ 12 Months (Responder)","Independent mCRC cohort with long PFS (≥12M). Targeted sequencing (EpiCORE assay) to refine predictive markers.",[22],"Diagnostic Test: EpiCORE Assay (Targeted Sequencing \u002F qPCR Validation)",{"label":24,"type":10,"description":25,"interventionNames":26},"Training Cohort - PFS \u003C 12 Months (Non-Responder)","Independent mCRC cohort with short PFS (\\\u003C12M). Targeted sequencing to validate resistance-associated markers.",[22],{"label":28,"type":10,"description":29,"interventionNames":30},"Validation Cohort - PFS ≥ 12 Months (Responder)","Independent validation cohort analyzed with qPCR-based EpiCORE assay to confirm biomarker predictive accuracy.",[22],{"label":32,"type":10,"description":33,"interventionNames":34},"Validation Cohort - PFS \u003C 12 Months (Non-Responder)","Independent validation cohort with poor PFS analyzed to assess specificity and model performance.",[22],[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"DIAGNOSTIC_TEST","cfDNA 5mC\u002F5hmC Sequencing (EpiCORE Discovery Phase)","Genome-wide profiling of cfDNA methylation and hydroxymethylation from pre-treatment plasma to identify molecular determinants associated with chemotherapy efficacy (PFS ≥ 12M vs \\\u003C 12M).",[15,9],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"EpiCORE Assay (Targeted Sequencing \u002F qPCR Validation)","Targeted validation of cfDNA 5mC\u002F5hmC markers from discovery phase using sequencing and qPCR to build and validate a predictive model for first-line chemotherapy response.",[24,19,32,28],[46],{"name":47,"affiliation":5,"role":48},"Ajay Goel, PhD","PRINCIPAL_INVESTIGATOR",[50],{"name":47,"role":51,"phone":52,"phoneExt":10,"email":53},"CONTACT","6263598111","ajgoel@coh.org",[55],{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Duarte","California","91010","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-117.97729,34.13945,{"lat":66,"lon":65},[69],{"name":47,"role":51,"phone":70,"phoneExt":10,"email":53},"626-218-3452",{"type":72,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100610225","cfdna-5mc5hmc-biomarkers-to-predict-chemotherapy-response-in-metastatic-colorectal-cancer-100610225",false,"NCT07224815","cfDNA 5mC\u002F5hmC Biomarkers to Predict Chemotherapy Response in Metastatic Colorectal Cancer","Development of a cfDNA 5mC\u002F5hmC-based Epigenetic Biomarker Panel to Predict Chemotherapy Efficacy in Metastatic Colorectal Cancer","EpiCORE","Inclusion Criteria:\n\n* Histologically confirmed metastatic colorectal adenocarcinoma (mCRC).\n* Received first-line chemotherapy (FOLFOX or FOLFIRI).\n* Availability of pre-treatment serum or plasma samples for cfDNA 5mC\u002F5hmC analysis.\n* Documented radiologic or clinical response evaluation (RECIST 1.1 or PFS-based).\n* RAS\u002FBRAF mutation status available.\n\nExclusion Criteria:\n\n* Inadequate cfDNA yield or poor DNA quality.\n* Non-adenocarcinoma histology.\n* Active inflammatory or autoimmune disease that may alter cfDNA methylation.\n* Concomitant malignancy requiring systemic therapy.","ALL","18 Years",{"count":84,"type":85},600,"ESTIMATED","OBSERVATIONAL","The EpiCORE study aims to identify cfDNA-based epigenetic markers predictive of response to first-line chemotherapy (FOLFOX or FOLFIRI) in metastatic colorectal cancer (mCRC).\n\nBy integrating 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) profiling, this study seeks to establish a non-invasive biomarker panel capable of distinguishing responders from non-responders.",[89],"CRC (Colorectal Cancer)",[91,92,93,94,95,96,97,98],"CRC","Colorectal cancer","5mC","5hmC","RAS\u002FBRAF mutation","FOLFOX","FOLFIRI","hydroxymethylation","2025-11-03",{"date":101,"type":102},"2025-11-05","ACTUAL",{"date":104,"type":102},"2024-06-21",{"date":106,"type":85},"2026-06-18",{"name":5,"class":6},1]