[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649822":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":52,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Servicio de Salud Metropolitano Sur Oriente","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective Stool Image, FIT and Colonoscopy Cohort",null,"Adults participating in colorectal cancer screening or diagnostic evaluation who submit stool images through the FAEX Health mobile application. AI-derived stool image outputs will be compared primarily with quantitative fecal immunochemical test results and FIT positivity. Colonoscopy and histopathology findings will be evaluated as secondary exploratory outcomes when available. AI-derived results will not be returned to participants or clinicians and will not influence clinical decisions.",[13],"Diagnostic Test: AI-Based Stool Image Analysis",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","AI-Based Stool Image Analysis","Participants capture stool images using the FAEX Health mobile application. Coded images are analyzed using artificial intelligence algorithms to derive visual features and a prespecified patient-level output or score. The AI-derived output is used exclusively for research and is compared primarily with quantitative FIT results and FIT positivity, with secondary comparisons against colonoscopy and histopathology when available. The output is not used to provide a diagnosis or guide clinical management.",[9],[21],{"name":22,"affiliation":23,"role":24},"Erik Manriquez Alegria, MD","Hospital Sotero Del Rio","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+56988232111","erik.manriquez.alegria@gmail.com",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Felipe Quezada Diaz, MD","+56934651992","ffquezad@gmail.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hospital Sotero del Rio","RECRUITING","Santiago","Santiago Metropolitan","8207257","Chile","CL",{"type":44,"coordinates":45},"Point",[46,47],-70.64827,-33.45694,{"lat":47,"lon":46},[50,51],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100649822","ai-based-stool-image-analysis-for-colorectal-neoplasia-risk-assessment-100649822",false,"NCT07740122","AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment","FECAL-AI: Prospective Observational Validation of AI-Based Stool Image Analysis Against Quantitative Fecal Immunochemical Testing for Colorectal Neoplasia Risk Assessment","FECAL-AI","Inclusion Criteria:\n\n* Age 18 years or older.\n* Referred for screening or diagnostic colonoscopy at Hospital Dr. Sótero del Río.\n* Quantitative fecal immunochemical testing planned or completed within 30 days before or after stool image submission.\n* Able to submit at least one stool image using the FAEX Health mobile application, independently or with assistance.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Unable or unwilling to provide written informed consent.\n* Previous enrollment in the study.\n* Unable to complete stool-image capture, even with assistance.\n* Study images and clinical data cannot be reliably linked using the assigned study code.","ALL","18 Years",{"count":65,"type":66},250,"ESTIMATED","1 Day","OBSERVATIONAL","This prospective observational substudy evaluates the association between artificial intelligence-derived features from stool images analyzed using the FAEX Health digital platform and fecal immunochemical test results in adults undergoing colorectal cancer screening or diagnostic evaluation. Participants will capture stool images using a mobile application. The primary analysis will compare AI-derived image outputs with quantitative FIT values and FIT positivity. Secondary exploratory analyses will assess associations with colonoscopy and histopathological findings when these results are available. The platform will be used exclusively for research and will not provide diagnoses, replace clinical evaluation, or influence medical decisions.",[71],"Colorectal Neoplasms",[73,74,75,76,77,78],"Colorectal Cancer Screening","Artificial Intelligence","Stool Image Analysis","Fecal Immunochemical Test","Colonoscopy","Digital Health","2026-07-28",{"date":81,"type":82},"2026-07-31","ACTUAL",{"date":84,"type":82},"2026-05-08",{"date":86,"type":66},"2026-12",{"name":5,"class":6},1]