[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610227":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":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"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 - Long PFS Group (Responder)",null,"Patients with metastatic colorectal cancer (mCRC) who received EGFR- or VEGF-targeted therapy and achieved a progression-free survival (PFS) ≥ 12 months, classified as clinical responders.\n\nPre-treatment plasma cfDNA samples were analyzed by genome-wide 5mC\u002F5hmC sequencing to identify epigenetic determinants associated with durable treatment response.",[13],"Diagnostic Test: cfDNA 5mC\u002F5hmC Sequencing (EpiDRIVE Discovery Phase)",{"label":15,"type":10,"description":16,"interventionNames":17},"Discovery Cohort - Short PFS Group (Non-Responder)","Patients with mCRC who received EGFR- or VEGF-targeted therapy and showed progression-free survival (PFS) \\\u003C 12 months, classified as non-responders.\n\nPre-treatment cfDNA samples were analyzed using genome-wide 5mC\u002F5hmC sequencing and compared with long-PFS responders to identify differential methylation and hydroxymethylation patterns associated with resistance.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Training Cohort - Long PFS Group (Responder)","Independent mCRC cohort with PFS ≥ 12 months following EGFR- or VEGF-targeted therapy.\n\nCandidate cfDNA 5mC\u002F5hmC markers identified in the discovery phase were validated using targeted sequencing (EpiDRIVE assay) to construct the predictive epigenetic biomarker panel.",[22],"Diagnostic Test: EpiDRIVE Assay (Targeted Sequencing \u002F qPCR Validation)",{"label":24,"type":10,"description":25,"interventionNames":26},"Training Cohort - Short PFS Group (Non-Responder)","Independent mCRC patients with PFS \\\u003C 12 months after targeted therapy. Targeted sequencing using the EpiDRIVE assay was conducted to refine and optimize the predictive model by comparing short- vs long-PFS cases.",[22],{"label":28,"type":10,"description":29,"interventionNames":30},"Validation Cohort - Long PFS Group (Responder)","Separate validation cohort of mCRC patients achieving PFS ≥ 12 months under EGFR- or VEGF-targeted therapy.\n\nqPCR-based EpiDRIVE assay was used to confirm predictive accuracy of the cfDNA 5mC\u002F5hmC biomarker panel in identifying durable responders.",[22],{"label":32,"type":10,"description":33,"interventionNames":34},"Validation Cohort - Short PFS Group (Non-Responder)","Independent validation cohort of mCRC patients with PFS \\\u003C 12 months after targeted therapy.\n\ncfDNA was analyzed using the qPCR-based EpiDRIVE assay to assess model specificity and distinguish non-responders from long-term responders.",[22],[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"DIAGNOSTIC_TEST","cfDNA 5mC\u002F5hmC Sequencing (EpiDRIVE Discovery Phase)","High-throughput genome-wide sequencing of cfDNA methylation (5mC) and hydroxymethylation (5hmC) profiles from pre-treatment plasma samples in the discovery cohort to identify epigenetic determinants of targeted-therapy response (PFS ≥ 12 months vs \\\u003C 12 months).",[9,15],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"EpiDRIVE Assay (Targeted Sequencing \u002F qPCR Validation)","Targeted sequencing or qPCR-based validation of cfDNA 5mC\u002F5hmC markers identified from the discovery phase to develop and validate a predictive biomarker model discriminating patients with long vs short progression-free survival after EGFR-\u002FVEGF-targeted therapy.",[19,24,28,32],[46],{"name":47,"affiliation":5,"role":48},"Ajay Goel, PhD","PRINCIPAL_INVESTIGATOR",[50],{"name":47,"role":51,"phone":52,"phoneExt":10,"email":53},"CONTACT","626-359-8111","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","91016","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","100610227","development-of-a-cfdna-5mc5hmc-based-biomarker-panel-to-predict-targeted-therapy-efficacy-in-mcrc-100610227",false,"NCT07224841","Development of a cfDNA 5mC\u002F5hmC-based Biomarker Panel to Predict Targeted Therapy Efficacy in mCRC","Development of a cfDNA 5mC\u002F5hmC-based Epigenetic Biomarker Panel to Identify Determinants of Response In VEGF\u002FEGFR-targeted Therapy for Metastatic Colorectal Cancer","EpiDRIVE","Inclusion Criteria:\n\n* Histologically confirmed metastatic colorectal adenocarcinoma (mCRC).\n* Received EGFR-targeted therapy (cetuximab\u002Fpanitumumab) or VEGF-targeted therapy (bevacizumab).\n* Availability of pre-treatment plasma sample for cfDNA analysis.\n* Documented radiologic response evaluation (RECIST 1.1).\n* RAS\u002FBRAF mutation status known.\n\nExclusion Criteria:\n\n* Inadequate cfDNA quality or low cfDNA yield.\n* Non-adenocarcinoma histology.\n* Concurrent or prior other active malignancy.\n* Active inflammatory or autoimmune disease affecting cfDNA methylation profiles.","ALL","18 Years",{"count":84,"type":85},500,"ESTIMATED","OBSERVATIONAL","The EpiDRIVE study aims to identify cfDNA-based epigenetic determinants of response in metastatic colorectal cancer (mCRC) patients treated with EGFR- or VEGF-targeted therapy.\n\nBy integrating 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) profiling, this study seeks to develop a predictive biomarker panel capable of differentiating responders from non-responders to targeted therapy.",[89],"CRC (Colorectal Cancer)",[91,92,93,94,95,96,97,98,99],"mCRC","Target therapy","5mc\u002F5hmc","5-hydroxymethylation","Metastatic colorectal cancer","anti-EGFR therapy","anti-VEGF therapy","RAS\u002FBRAF mutation","5-methylcytosine","2025-11-03",{"date":102,"type":103},"2025-11-05","ACTUAL",{"date":105,"type":103},"2024-06-21",{"date":107,"type":85},"2026-06-18",{"name":5,"class":6},1]