[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627590":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":43,"centralContacts":48,"locations":55,"responsibleParty":111,"collaborators":10,"id":113,"slug":10,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":40,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":119,"minAge":120,"maxAge":10,"enrollmentInfo":121,"targetDuration":10,"studyType":124,"phases":10,"briefSummary":125,"conditions":126,"keywords":10,"overallStatus":95,"whyStopped":10,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"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",[56,82,93,102],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital","NOT_YET_RECRUITING","Milan","Lombardy","20132","Italy",{"type":64,"coordinates":65},"Point",[66,67],9.18951,45.46427,{"lat":67,"lon":66},[70,71,73,75,77,80],{"name":45,"role":50,"phone":10,"phoneExt":10,"email":52},{"name":72,"role":47,"phone":10,"phoneExt":10,"email":10},"Alessandro Mannucci, MD",{"name":74,"role":47,"phone":10,"phoneExt":10,"email":10},"Marta Puzzono, MD, PhD",{"name":76,"role":47,"phone":10,"phoneExt":10,"email":10},"Clelia Di Serio, PhD",{"name":78,"role":79,"phone":10,"phoneExt":10,"email":10},"Chiara Brombin, PhD","SUB_INVESTIGATOR",{"name":81,"role":79,"phone":10,"phoneExt":10,"email":10},"Paola MV Rancoita, PhD",{"facility":83,"status":58,"city":59,"state":60,"zip":61,"country":62,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Prof Giulia Martina Cavestro, MD PhD",{"type":64,"coordinates":85},[66,67],{"lat":67,"lon":66},[88,91,92],{"name":45,"role":50,"phone":89,"phoneExt":90,"email":52},"0226435508","+39",{"name":74,"role":47,"phone":10,"phoneExt":10,"email":10},{"name":72,"role":47,"phone":10,"phoneExt":10,"email":10},{"facility":94,"status":95,"city":59,"state":60,"zip":61,"country":62,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit","RECRUITING",{"type":64,"coordinates":97},[66,67],{"lat":67,"lon":66},[100],{"name":101,"role":50,"phone":10,"phoneExt":10,"email":52},"Giulia Martina Cavestro, MD PhD",{"facility":103,"status":58,"city":59,"state":104,"zip":10,"country":62,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori","MI",{"type":64,"coordinates":106},[66,67],{"lat":67,"lon":66},[109],{"name":110,"role":50,"phone":10,"phoneExt":10,"email":10},"Marco Vitellaro, MD",{"type":112,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":122,"type":123},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.",[127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145],"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":148,"type":149},"2026-03-04","ACTUAL",{"date":151,"type":149},"2024-01-01",{"date":153,"type":123},"2031-08-15",{"name":5,"class":6},4]