[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569480":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":24,"responsibleParty":44,"collaborators":48,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"discover cohort",null,"The discover cohort will consist in patients already collected",{"label":13,"type":10,"description":14,"interventionNames":10},"Validation cohort","The validation cohort will include patients enrolled prospectively during the first year of the study",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Stefano Crippa, MD","CONTACT","+390226436046","crippa.stefano@hsr.it",{"name":22,"role":18,"phone":19,"phoneExt":10,"email":23},"Gabriele Capurso, MD","capurso.gabriele@hsr.it",[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"San Raffaele Hospital","RECRUITING","Milan","MI","20132","Italy","IT",{"type":34,"coordinates":35},"Point",[36,37],12.59836,42.78235,{"lat":37,"lon":36},[40],{"name":41,"role":18,"phone":42,"phoneExt":10,"email":43},"Francesca Di Salvo, PhD","0226437810","disalvo.francesca@hsr.it",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Stefano Crippa","Associate Professor",[49,51,53],{"name":50,"class":6},"University of Pisa",{"name":52,"class":6},"Casa Sollievo della Sofferenza IRCCS",{"name":54,"class":6},"The Mediterranean Institute for Transplantation and Advanced Specialized Therapies","100569480","integration-of-multiomics-markers-for-invasive-ipmns-identification-through-the-set-up-of-the-invasive-cyst-biomarkers-detection-incite-consortium-100569480",false,"NCT06694792","Integration of Multiomics Markers for Invasive IPMNs Identification Through the Set-up of the INvasive Cyst bIomarkers Detection (INCITE) Consortium","INCITE","Inclusion Criteria:\n\n* Adult (age \\>18 years) patients with a diagnosis of IPMN undergoing and not undergoing surgery\n* All patients will sign the informed consent\n\nFor the retrospective patients:\n\n* confirmed IPMN diagnosis\n* signed informed consent for samples biobanking and study participation\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years of age\n* Patients who are not able to supply an informed consent","ALL","18 Years",{"count":65,"type":66},800,"ESTIMATED","OBSERVATIONAL","Although intraductal papillary mucinous neoplasms (IPMNs) represent potential precursors of pancreatic cancer, IPMNs with invasive cancer are rare. Based on current risk factors for malignancy, overtreatment (surgery) of benign IPMNs remains a critical issue, with its associated risk of postoperative and long-term complications.\n\nIdentification of biomarkers that could predict malignancy in IPMNs is an unmet clinical need. Environmental, lifestyle, genetics and metabolic factors may play a role in IPMNs carcinogenesis. Aims of the study are: 1) to analyze exposome, somatic\u002Fgermline genetic variability, metabolomics and transcriptome profile in order to identify new biomarkers; 2) to use nonparametric epidemiologic approaches and machine learning algorithms to compute a progression score to offer clinicians an innovative tool towards the goal of a personalized medicine approach. In order to perform all the analysis we will set up the Invasive Cyst biomarker detection (INCITE) consortium, between the participant centers in order to collectively enroll an adequate number of patients to fulfill the previous aims.\n\nThe project is designed as an observational cross-sectional multicenter study with additional procedures. The analysis will be conducted on biological samples collected at a single time point. Some samples (500 patients: 160 surgical, 340 under surveillance) are already available in the consortium, having been collected in previous studies, while additional 300 (100 surgical and 200 under surveillance) patients will be prospectively enrolled during the first 12 months of the study.\n\nThe sample collection will take place during outpatient visit\u002FEUS procedure for the surveillance cohort, while in the surgical cohort all the material will be retrieved during the surgery. The patients samples will be divided in two cohorts, the first will be a discovery cohort and the second one a validation cohort. The first cohort will consist in patients already collected. The validation cohort will include patients enrolled prospectively during the first year of the study.",[70],"IPMN, Pancreatic",[72,73,74],"IPMN","pancreatic disease","multiomics markers","2025-11-16",{"date":77,"type":78},"2025-11-19","ACTUAL",{"date":80,"type":78},"2025-01-03",{"date":82,"type":66},"2026-12-31",{"name":5,"class":6},1]