[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605926":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":24,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":68,"collaborators":24,"id":70,"slug":24,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":24,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":51,"whyStopped":24,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Epiliquid Holding, Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"Sensitivity of colorectal cancer detection","Sensitivity and specificity of the Delta-HLD test for detection of colorectal cancer","18 months",{"measure":14,"description":15,"timeFrame":16},"Specificity of advanced neoplasia detection","Specificity of colorectal cancer detection","36 months",[18,21],{"measure":19,"description":20,"timeFrame":16},"Accuracy of colorectal cancer precursor lesions detection","Sensitivity and specificity of of colorectal cancer precursor lesions detection",{"measure":22,"description":23,"timeFrame":16},"Predictive values","Positive predictive value (PPV) and negative predictive value (NPV) of the Delta-HLD test for CRC detection",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","CROSS_SECTIONAL","Colorectal cancer (CRC) is one of the most common cancers worldwide and among the leading causes of cancer-related mortality. Early detection substantially improves survival; however, adherence to existing screening strategies remains suboptimal across different regions. CLIMBED is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of Epiliquid's Delta-HLD liquid biopsy technology, which detects methylation-based epigenetic biomarkers in plasma using PCR. The study will enroll 3200 participants between 45 and 75 years of age, representing an average-risk CRC population. All participants will undergo screening colonoscopy, which will serve as the gold standard for comparison. The primary endpoints are sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Delta-HLD technology for CRC detection in cfDNA. Secondary endpoints include the capacity of the test to identify precursor lesions. Statistical analysis will be based on ROC curves and AUC to determine diagnostic performance.","Single cohort of adults aged 45 and 75 years, representing an average-risk CRC population, undergoing routine colorectal cancer screening with colonoscopy in Argentina as standard of care.",[31],{"label":32,"type":24,"description":24,"interventionNames":24},"Cases: Average-risk population undergoing colorectal cancer screening colonoscopy",[34],{"name":35,"affiliation":36,"role":37},"Emanuel Campoy, PhD","CONICET-National Scientific and Technical Research Council","STUDY_DIRECTOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},"Dr. Victoria Bocanegra, MD, PhD.","CONTACT","+5492616603254","victoria.bocanegra@epiliquid.com",{"name":45,"role":41,"phone":46,"phoneExt":24,"email":47},"Dr. Emanuel Campoy, PhD.","+5492615997899","emanuel.campoy@epiliquid.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Epiliquid","RECRUITING","Mendoza","Mendoza Province","5500","Argentina","AR",{"type":58,"coordinates":59},"Point",[60,61],-68.84582,-32.88946,{"lat":61,"lon":60},[64],{"name":65,"role":41,"phone":66,"phoneExt":24,"email":67},"Alejandro Ledesma, M.Sc","+549 1140681732","alejandro.ledesma@epiliquid.com",{"type":69,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100605926",false,"NCT07168876","Colon Cancer Liquid Biopsy Investigation of Methylation-based Biomarkers Evaluation Using Delta-HLD (CLIMBED)","Clinical Validation Cross-sectional Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CLIMBED)","CLIMBED","Inclusion Criteria:\n\n* Men and women aged 45-75 years\n* Indication of colorectal cancer screening colonoscopy by treating physician\n\nExclusion Criteria:\n\n* First-degree family history of CRC\n* Inflammatory bowel disease (ulcerative colitis, Crohn's disease)\n* Other malignancies within 5 years\n* Known hereditary CRC syndromes (Lynch, FAP)\n* Major trauma, surgery, transfusion in past 30 days\n* Current participation in an interventional clinical trial",true,"ALL","45 Years","75 Years",{"count":82,"type":83},3200,"ESTIMATED","OBSERVATIONAL","CLIMBED (Colon cancer Liquid biopsy Investigation of Methylation-based Biomarkers Evaluation using Delta-HLD) is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of Delta-HLD, Epiliquid's proprietary liquid biopsy technology, for colorectal cancer (CRC) detection. The study will evaluate the test performance in an average-risk population for CRC undergoing screening colonoscopy, which will serve as the gold standard reference.",[87],"Colorectal Cancer (CRC)",[89,90,91,92,93,94,95],"Colorectal cancer","Epigenetics","Liquid biopsy","cfDNA","Biomarker","Methylarion","PCR","2025-09-04",{"date":98,"type":99},"2025-09-11","ACTUAL",{"date":101,"type":99},"2024-04-04",{"date":103,"type":83},"2028-12",{"name":5,"class":6},1]