[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570396":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":28,"responsibleParty":45,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Cohort A",null,"A retrospective study of a cohort of 350 resected patients with a histologically-confirmed IPMN, diagnosed from the 1st January 2009 to the 31st May 2018 following these inclusion criteria:\n\n* histologically proven IPMNs with full pathological data (type of IPMNs, grade of dysplasia; for invasive IPMNs: grading, pTNM classification, presence of perineural (microvascular infiltration)\n* availability of clinical and imaging criteria for surgical resections defined by International and European guidelines (worrisome features and high-risk stigmata according to International Guidelines and absolute\u002Frelative criteria for surgery according to European guidelines\n* age ≥18 years and exclusion criteria:\n* lack of preoperative clinical and radiological data according the two guidelines",{"label":13,"type":10,"description":14,"interventionNames":10},"Cohort B","A prospective observational study whose aim is to identify EMI profiles and radiological\u002Fendosonographical biomarker(s) associated to surgically removed IPMNs with HGD\u002FIC.\n\nPatients diagnosed with IPMN and candidates for resection with following inclusion criteria will be enrolled:\n\n* Age \\>= 18 years\n* Charlson comorbidity index \\\u003C7 \\[26\\] The patients' cohort will be selected following the best criteria for surgery identified in the retrospective study (Cohort A).\n\nAt the admission, patients will be informed by PI, or his delegates about the study, and they will be asked to sign the specific informed consents (see par. 5.1) In the course of standard pre-operative evaluation, all patients will undergo MRI and EUS, within no more than 3 months between exams.",{"label":16,"type":10,"description":17,"interventionNames":10},"Cohort C","A prospective study with the aim to validate potential biomarker(s) identified in the Cohort B.\n\nPatients with a diagnosis of IPMN candidate for resection with the following inclusion criteria will be enrolled:\n\n* Age \\>= 18 years\n* Charlson comorbidity index \\\u003C7 \\[26\\] The patients' cohort will be selected following the best criteria for surgery identified in the retrospective study (Cohort A).\n\nAt the admission patients will be informed by PI or his delegates about the study and they will be asked to sign specific informed consents",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Stefano Crippa, MD","CONTACT","+39 0226437811","crippa.stefano@hsr.it",{"name":25,"role":21,"phone":26,"phoneExt":10,"email":27},"Paolo Camisa, MD","+39 0226436046","camisa.paoloriccardo@hsr.it",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":33,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"San Raffaele Hospital","RECRUITING","Milan","Italy","20132","IT",{"type":37,"coordinates":38},"Point",[39,40],9.18951,45.46427,{"lat":40,"lon":39},[43,44],{"name":20,"role":21,"phone":26,"phoneExt":10,"email":23},{"name":20,"role":21,"phone":10,"phoneExt":10,"email":10},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Stefano Crippa","Associate Professor","100570396","endocrine-metabolic-inflammatory-biomarkers-to-identify-highgrade-dysplasiainvasive-carcinoma-in-patients-with-ipmn-of-the-pancreas-100570396",false,"NCT06706700","Endocrine, Metabolic, Inflammatory Biomarkers to Identify Highgrade Dysplasia\u002Finvasive Carcinoma in Patients with IPMN of the Pancreas","Definition of Radiological and Endocrine\u002Fmetabolic\u002Finflammatory Biomarker(s) to Identify Highgrade Dysplasia\u002Finvasive Carcinoma in Patients with Intraductal Papillary Mucinous Neoplasms of the Pancreas","EMI-IPMN","cohort A: inclusion criteria:\n\n* histologically proven IPMNs with full pathological data (type of IPMNs, grade of dysplasia; for invasive IPMNs: grading, pTNM classification, presence of perineural (microvascular infiltration)\n* availability of clinical and imaging criteria for surgical resections defined by International and European guidelines (worrisome features and high-risk stigmata according to International Guidelines and absolute\u002Frelative criteria for surgery according to European guidelines\n* age ≥18 years\n\nexclusion criteria:\n\n\\- lack of preoperative clinical and radiological data according the two guidelines\n\nCohort B and C:\n\ninclusion criteria:\n\n* Age \\>= 18 years\n* Charlson comorbidity index \\\u003C7\n* indication for surgery for suspected IPMN","ALL","18 Years",{"count":60,"type":61},586,"ESTIMATED","OBSERVATIONAL","Under the hypotheses that a more accurate patients selection could limit the problem of overtreatment and that benign intraductal papillary mucinous neoplasms (IPMN) have a distinguishable Endocrine\u002FMetabolic\u002FInflammatory (EMI) profile from those with high-grade disease\u002Finvasive carcinoma, this study has three specific aims. The first aim is to evaluate and confirm the accuracy of the updated versions of International and European guidelines for the management of IPMN and it will be addressed by retrospectively applying the criteria included in the two guidelines on 350 patients with resected IPMN in order to determine the most accurate criteria to identify High Grade Dysplasia(HGD)\u002FInvasive Carcinoma (IC).\n\nThe second aim is to identify pre-operative biological and\u002For radiological\u002Fendosonographic biomarker(s) able to distinguish low- versus high-risk IPMN for cancer progression in a prospective study by enrolling a cohort of 186 (of which 145 surgically-resected) patients.\n\nThe third aim is to prospectively validate biological and\u002For radiological\u002Fendosonographic biomarker(s) (previously identified and optimized) on a new cohort of 50 patients with IPMN undergoing surgical resection.",[65,66],"Intraductal Papillary Mucinous Neoplasm of Pancreas","Pancreatic Cyst",[68,69,70],"ipmn","intraductal papillary mucinous neoplasm of the pancreas","Pancreatic Cysts","2024-11-22",{"date":73,"type":74},"2024-11-26","ACTUAL",{"date":76,"type":74},"2020-07-13",{"date":78,"type":61},"2025-03-31",{"name":5,"class":6},1]