[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610328":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":45,"centralContacts":49,"locations":54,"responsibleParty":70,"collaborators":10,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":10,"enrollmentInfo":82,"targetDuration":10,"studyType":85,"phases":10,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"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 - NAC Responder Group",null,"Patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC) who received neoadjuvant chemotherapy (FOLFIRINOX or gemcitabine plus nab-paclitaxel) and achieved a clinical or pathological response.\n\nResponders were defined as patients showing complete response (CR), partial response (PR), or stable disease (SD) according to radiologic or pathologic assessment after NACT.\n\nPre-treatment plasma samples from these patients were analyzed by small RNA sequencing to identify microRNAs associated with favorable chemotherapy response.",[13],"Diagnostic Test: Small RNA sequencing",{"label":15,"type":10,"description":16,"interventionNames":17},"Discovery Cohort - NAC Non-Responder Group","Patients with resectable or borderline resectable PDAC who received neoadjuvant chemotherapy but demonstrated progressive disease (PD) on radiologic or pathologic evaluation.\n\nPre-treatment plasma samples from these patients were analyzed in parallel by small RNA sequencing to identify differential miRNA expression compared with responders.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Training Cohort - NAC Responder Group","PDAC patients treated with neoadjuvant chemotherapy (FOLFIRINOX or gemcitabine plus nab-paclitaxel) who achieved CR, PR, or SD responses.\n\nCandidate microRNAs identified in the Discovery cohort were validated using qRT-PCR (PRECEPT assay).\n\nResponder group data were used to train and optimize the predictive miRNA panel.",[22],"Diagnostic Test: PRECEPT assay (qRT-PCR validation)",{"label":24,"type":10,"description":25,"interventionNames":26},"Training Cohort - NAC Non-Responder Group","PDAC patients who received neoadjuvant chemotherapy but exhibited progressive disease (PD).\n\nPlasma miRNA expression was measured using the PRECEPT assay and compared with responders to refine the predictive model for chemotherapy response.",[22],{"label":28,"type":10,"description":29,"interventionNames":30},"Validation Cohort - NAC Responder Group","A separate validation cohort of PDAC patients treated with neoadjuvant chemotherapy who achieved CR, PR, or SD.\n\nThe established PRECEPT miRNA panel (qRT-PCR) was applied to evaluate predictive accuracy in this independent responder group.",[22],{"label":32,"type":10,"description":33,"interventionNames":34},"Validation Cohort - NAC Non-Responder Group","Independent PDAC patients who received neoadjuvant chemotherapy and demonstrated progressive disease (PD).\n\nThis cohort was used to confirm the predictive performance and robustness of the PRECEPT miRNA assay compared with responders.",[22],[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"DIAGNOSTIC_TEST","Small RNA sequencing","High-throughput small RNA sequencing performed on pre-treatment plasma samples from PDAC patients in the Discovery cohort to identify candidate microRNAs associated with neoadjuvant chemotherapy response. Sequencing data were analyzed to detect differentially expressed miRNAs between responder (CR + PR + SD) and non-responder (PD) groups.",[15,9],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"PRECEPT assay (qRT-PCR validation)","Quantitative reverse transcription PCR (qRT-PCR)-based validation assay performed on pre-treatment plasma samples in the Training and Validation cohorts. Candidate microRNAs identified in the Discovery cohort by small RNA sequencing were tested using the PRECEPT assay to develop and validate a predictive miRNA panel for neoadjuvant 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","626-218-3452","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":52,"phoneExt":10,"email":53},{"type":71,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100610328","prediction-of-neoadjuvant-chemotherapy-response-in-pancreatic-cancer-100610328",false,"NCT07226154","Prediction of Neoadjuvant Chemotherapy Response in Pancreatic Cancer","An Exosomal miRNA Based Predictive Model for Personalized Neoadjuvant Chemotherapy Selection in Pancreatic Ductal Adenocarcinoma","PRECEPT","Inclusion Criteria:\n\n* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).\n* Underwent neoadjuvant chemotherapy (FOLFIRINOX or Gemcitabine\u002Fnab-paclitaxel).\n* Availability of pre-treatment plasma samples.\n* Underwent curative-intent resection (R0 or R1).\n\nExclusion Criteria:\n\n* Inadequate plasma samples or poor RNA quality for exosomal miRNA analysis.\n* Non-adenocarcinoma histology.\n* Presence of synchronous or multiple primary malignancies.\n* Receipt of chemotherapy regimens other than standard FOLFIRINOX or gemcitabine plus nab-paclitaxel (GEM-NABP).\n* Presence of active inflammatory or autoimmune diseases.","ALL","18 Years",{"count":83,"type":84},200,"ESTIMATED","OBSERVATIONAL","This study aims to develop and validate a predictive microRNA (miRNA) panel to assess the response to neoadjuvant chemotherapy (NACT) in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC).",[88],"Pancreatic Ductal Adenocarcinoma",[90,91,92,93,94,95],"PDAC","Exosome","miRNA","FOLFIRINOX","gemcitabine plus nab-paclitaxel","neoadjuvant chemotherapy","2026-08-18",{"date":98,"type":99},"2026-08-19","ACTUAL",{"date":101,"type":99},"2024-11-15",{"date":103,"type":84},"2026-12-01",{"name":5,"class":6},1]