[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627590":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":43,"centralContacts":48,"locations":55,"responsibleParty":112,"collaborators":10,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":40,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":10,"enrollmentInfo":123,"targetDuration":10,"studyType":126,"phases":10,"briefSummary":127,"conditions":128,"keywords":10,"overallStatus":96,"whyStopped":10,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"San Raffaele University","OTHER",[8,14,18,22,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Lynch syndrome, without Lynch-syndrome associated cancers",null,"Individuals with Lynch syndrome, who are free of Lynch-syndrome associated cancers at the time of blood drawing",[13],"Diagnostic Test: BEACON",{"label":15,"type":10,"description":16,"interventionNames":17},"Lynch syndrome, with Lynch-syndrome associated cancers","Individuals with Lynch syndrome, who have one (or more) Lynch-syndrome associated cancer(s) at the time of blood drawing",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Colorectal cancer","Individuals with sporadic biopsy-proven colorectal cancer, as identified during routine colonoscopy and diagnosed via pathological review",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Advanced adenoma","Individuals with sporadic advanced adenomas, defined as (i) more than 3 colorectal polyps, (ii) presence of high-grade dysplasia in one or more polyp, or (iii) polyp(s) \\>10 mm",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Colonoscopy-negative controls","Individuals whose colonoscopy was negative for colorectal cancer and for advanced colorectal adenomas",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Pre-treatment samples","Individuals with (i) colorectal cancer, or (ii) advanced adenomas, or (iii) Lynch syndrome associated cancer(s) will have the possibility to participate to a sub-analysis of this study, where their circulating plasma levels of biomarkers will be evaluated prior to resection (treatment-naive) and post-resection (to measure the molecular persistence of the disease after the resection)",[13],{"label":35,"type":10,"description":32,"interventionNames":36},"Post-treatment samples",[13],[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"DIAGNOSTIC_TEST","BEACON","A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples",[23,27,19,15,9,35,31],[44],{"name":45,"affiliation":46,"role":47},"Giulia Martina Cavestro, MD, PhD","IRCCS San Raffaele Hospital","PRINCIPAL_INVESTIGATOR",[49,53],{"name":45,"role":50,"phone":51,"phoneExt":10,"email":52},"CONTACT","0226437217","cavestro.giuliamartina@hsr.it",{"name":54,"role":50,"phone":51,"phoneExt":10,"email":52},"Giulia Martina Cavestro",[56,83,94,103],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital","NOT_YET_RECRUITING","Milan","Lombardy","20132","Italy","IT",{"type":65,"coordinates":66},"Point",[67,68],9.18951,45.46427,{"lat":68,"lon":67},[71,72,74,76,78,81],{"name":45,"role":50,"phone":10,"phoneExt":10,"email":52},{"name":73,"role":47,"phone":10,"phoneExt":10,"email":10},"Alessandro Mannucci, MD",{"name":75,"role":47,"phone":10,"phoneExt":10,"email":10},"Marta Puzzono, MD, PhD",{"name":77,"role":47,"phone":10,"phoneExt":10,"email":10},"Clelia Di Serio, PhD",{"name":79,"role":80,"phone":10,"phoneExt":10,"email":10},"Chiara Brombin, PhD","SUB_INVESTIGATOR",{"name":82,"role":80,"phone":10,"phoneExt":10,"email":10},"Paola MV Rancoita, PhD",{"facility":84,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"Prof Giulia Martina Cavestro, MD PhD",{"type":65,"coordinates":86},[67,68],{"lat":68,"lon":67},[89,92,93],{"name":45,"role":50,"phone":90,"phoneExt":91,"email":52},"0226435508","+39",{"name":75,"role":47,"phone":10,"phoneExt":10,"email":10},{"name":73,"role":47,"phone":10,"phoneExt":10,"email":10},{"facility":95,"status":96,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit","RECRUITING",{"type":65,"coordinates":98},[67,68],{"lat":68,"lon":67},[101],{"name":102,"role":50,"phone":10,"phoneExt":10,"email":52},"Giulia Martina Cavestro, MD PhD",{"facility":104,"status":58,"city":59,"state":105,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori","MI",{"type":65,"coordinates":107},[67,68],{"lat":68,"lon":67},[110],{"name":111,"role":50,"phone":10,"phoneExt":10,"email":10},"Marco Vitellaro, MD",{"type":113,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100627590","liquid-biopsy-and-machine-learning-for-early-colorectal-cancer-adenomas-lynch-cancers-and-residual-disease-detection-100627590",false,"NCT07450612","Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection","Inclusion Criteria:\n\n* All individuals included in the study need to have had a colonoscopy at the time of blood sampling.\n* Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.\n* Received standard pathological and endoscopic diagnosis and assessment for cohort assignment\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Inflammatory bowel disease",true,"ALL","18 Years",{"count":124,"type":125},1200,"ESTIMATED","OBSERVATIONAL","This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for molecular residual disease monitoring purposes.",[129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147],"Colorectal Cancer","Adenoma Colon","Adenoma Colon Polyp","Colon Adenoma","Colo-rectal Cancer","Colon Disease","Colon Neoplasm","Lynch Syndrome","Lynch Syndrome I","Lynch Syndrome II","Lynch Syndrome I (Site-specific Colonic Cancer)","LYN Gene Mutation","Mismatch Repair Deficiency","Mismatch Repair Gene Mutation","MLH1 Gene Mutation","MSH2 Gene Mutation","MSH6 Gene Mutation","PMS2 Gene Mutation","EPCAM Gene Mutation","2026-02-27",{"date":150,"type":151},"2026-03-04","ACTUAL",{"date":153,"type":151},"2024-01-01",{"date":155,"type":125},"2031-08-15",{"name":5,"class":6},4]