[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608251":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":42,"centralContacts":46,"locations":51,"responsibleParty":84,"collaborators":86,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":37,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":10,"enrollmentInfo":97,"targetDuration":10,"studyType":100,"phases":10,"briefSummary":101,"conditions":102,"keywords":112,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Individuals with duodenal advanced neoplasia (Training cohort)",null,"Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the training cohort (aka, cases)",[13],"Diagnostic Test: DRACO",{"label":15,"type":10,"description":16,"interventionNames":17},"Individuals with duodenal advanced neoplasia (validation cohort)","Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the validation cohort (aka, cases)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Individuals with duodenal advanced neoplasia (Testing cohort)","Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the testing cohort (aka, cases)",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Individuals without duodenal advanced neoplasia (Training cohort)","Individuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the training cohort (aka, controls)",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Individuals without duodenal advanced neoplasia (Validation cohort)","Individuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the validation cohort (aka, controls)",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Individuals without duodenal advanced neoplasia (Testing cohort)","Individuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the testing cohort (aka, controls)",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DIAGNOSTIC_TEST","DRACO","A novel endoscopic classification to predict the risk of duodenal and ampullary high-grade dysplasia and cancer from baseline esophagogastroduodenoscopy (EGD)",[19,9,15,31,23,27],[41],"Duodenal Risk Assessment in adenomatous polyposis Coli Oncogene",[43],{"name":44,"affiliation":5,"role":45},"Marco Vitellaro, M.D.","STUDY_CHAIR",[47],{"name":44,"role":48,"phone":49,"phoneExt":10,"email":50},"CONTACT","+393480197920","marco.vitellaro@istitutotumori.mi.it",[52,75],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"IRCCS Ospedale San Raffaele","RECRUITING","Milan","MI","20129","Italy","IT",{"type":61,"coordinates":62},"Point",[63,64],12.59836,42.78235,{"lat":64,"lon":63},[67,70,72],{"name":68,"role":48,"phone":10,"phoneExt":10,"email":69},"Giulia Martina Cavestro, M.D., Ph.D.","cavestro.giuliamartina@hsr.it",{"name":68,"role":71,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":73,"role":74,"phone":10,"phoneExt":10,"email":10},"Alessandro Mannucci, M.D.","SUB_INVESTIGATOR",{"facility":76,"status":54,"city":55,"state":10,"zip":77,"country":58,"countryCode":59,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Fondazione IRCCS Istituto Nazionale dei Tumori","20133",{"type":61,"coordinates":79},[63,64],{"lat":64,"lon":63},[82,83],{"name":44,"role":48,"phone":10,"phoneExt":10,"email":10},{"name":44,"role":71,"phone":10,"phoneExt":10,"email":10},{"type":85,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[87],{"name":53,"class":6},"100608251","duodenal-polyposis-classification-in-fap-100608251",false,"NCT07199127","Duodenal Polyposis Classification in FAP","Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis","Inclusion Criteria:\n\n* Confirmed germline diagnosis of FAP, as defined by genetic testing\n* Two or more upper gastrointestinal endoscopies\n* Complete documentation of all Spigelman classification variables at each endoscopic evaluation\n\nExclusion Criteria:\n\n* Histological grading of duodenal polyps incomplete\n* Follow-up data were unavailable\n* Duodenal surgery before study baseline endoscopy","ALL","18 Years",{"count":98,"type":99},300,"ESTIMATED","OBSERVATIONAL","Duodenal cancer is the leading cause of cancer-related mortality in patients with familial adenomatous polyposis (FAP), yet the current Spigelman staging system provides limited predictive accuracy for advanced neoplasia. The DRACO study (Duodenal Risk Assessment in adenomatous polyposis Coli -Oncogene) is a multicenter, STROBE- and CONSORT-compliant cohort study that analyzes upper endoscopies from genetically confirmed FAP patients across independent cohorts to develop, validate, and externally test two multivariable risk models.",[103,104,105,106,107,108,109,110,111],"Duodenum Cancer","Familial Adenomatous Polyposis","Duodenal Polyposis","Ampulla of Vater Adenoma","FAP Gene Mutation","FAP","Duodenal Neoplasms","Duodenal Adenoma","Ampulla of Vater Cancer",[113,105],"Spigelman","2025-09-22",{"date":116,"type":117},"2025-09-30","ACTUAL",{"date":119,"type":117},"2018-02-02",{"date":121,"type":99},"2030-01-15",{"name":5,"class":6},2]