[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558331":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":54,"centralContacts":58,"locations":63,"responsibleParty":268,"collaborators":29,"id":270,"slug":271,"hasResults":272,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":29,"eligibilityCriteria":275,"healthyVolunteers":276,"sex":277,"minAge":278,"maxAge":29,"enrollmentInfo":279,"targetDuration":29,"studyType":282,"phases":283,"briefSummary":285,"conditions":286,"keywords":29,"overallStatus":66,"whyStopped":29,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":300},{"fullName":5,"class":6},"Lipidica, a.s.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Pancreatic cancer","ACTIVE_COMPARATOR","Participants with histologically confirmed diagnosis of resectable Pancreatic cancer.\n\nArm 1 will undertake one visit (baseline) for blood sampling - lipidomics, CA 19-9 and CEA, HbA1c.\n\nAt baseline their participation ends.",[13,14],"Device: software Lipidica","Diagnostic Test: laboratory examination",{"label":16,"type":17,"description":18,"interventionNames":19},"Patient at risk of Pancreatic cancer","EXPERIMENTAL","Participants without Pancreatic cancer but at higher risk of this cancer disease due to their predispositions.\n\nArm 2 will come for two or three visits depending on results at baseline. On each visit blood sampling (lipidomics, CA 19-9 and CEA, HbA1c, hCG) and medical imaging by EUS, MR or CT will be performed.\n\nTheir participation ends with the diagnosis of Pancreatic cancer or after 12 months of follow-up.",[13,20,21,14,22],"Procedure: endoscopic ultrasonography","Procedure: magnetic resonance","Procedure: computed tomography",[24,30,37,43,48],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","software Lipidica","The investigational in vitro diagnostic medical device-software (IVDSW) \"Lipidica\" processes and analyses data inputs from the analysis of lipid profile in human plasma using an in-house in vitro diagnostic medical device.",[16,9],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"PROCEDURE","endoscopic ultrasonography","Endoscopic ultrasonography - maximum frequency: 3 times during the participation",[16],[36],"EUS",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"magnetic resonance","Magnetic resonance - maximum frequency: 3 times during the participation",[16],[42],"MR",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":29},"DIAGNOSTIC_TEST","laboratory examination","Lipidomic analysis, CA 19-9, CEA, HbA1c and hCG levels assessment (hCG only in women of childbearing potential in Arm 2)",[16,9],{"type":31,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"computed tomography","computed tomography - maximum frequency: 3 times during the participation",[16],[53],"CT",[55],{"name":56,"affiliation":5,"role":57},"Karolina Kasparova","STUDY_DIRECTOR",[59],{"name":56,"role":60,"phone":61,"phoneExt":29,"email":62},"CONTACT","+420723 242 544","karolina.kasparova@lipidica.cz",[64,82,95,105,116,130,144,159,172,186,199,209,222,233,243,254],{"facility":65,"status":66,"city":67,"state":68,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Ustredni vojenska nemocnice","RECRUITING","Prague","Czechia",{"type":70,"coordinates":71},"Point",[72,73],14.42076,50.08804,{"lat":73,"lon":72},[76,80],{"name":77,"role":60,"phone":78,"phoneExt":29,"email":79},"Jan Csomor","+420973203028","Jan.Csomor@uvn.cz",{"name":77,"role":81,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"facility":83,"status":66,"city":84,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Fakultni nemocnice Brno","Brno",{"type":70,"coordinates":86},[87,88],16.60796,49.19522,{"lat":88,"lon":87},[91,94],{"name":92,"role":60,"phone":29,"phoneExt":29,"email":93},"Jan Hlavsa","Hlavsa.Jan@fnbrno.cz",{"name":92,"role":81,"phone":29,"phoneExt":29,"email":29},{"facility":96,"status":66,"city":84,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Fakultni nemocnice u sv. 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Varejkova","varejkova.barbora@nemcb.cz",{"name":129,"role":81,"phone":29,"phoneExt":29,"email":29},"Filip Shon",{"facility":131,"status":66,"city":132,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Fakultni nemocnice Hradec Kralove","Hradec Králové",{"type":70,"coordinates":134},[135,136],15.83277,50.20923,{"lat":136,"lon":135},[139,142],{"name":140,"role":60,"phone":29,"phoneExt":29,"email":141},"Veronika Knoblochova","veronika.knoblochva@fnhk.cz",{"name":143,"role":81,"phone":29,"phoneExt":29,"email":29},"Tomas Douda",{"facility":145,"status":146,"city":147,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Nemocnice Jablonec nad Nisou","NOT_YET_RECRUITING","Jablonec nad Nisou",{"type":70,"coordinates":149},[150,151],15.17108,50.72431,{"lat":151,"lon":150},[154,158],{"name":155,"role":60,"phone":156,"phoneExt":29,"email":157},"Robert Prochazka","+420721122793","prochazka@nemjbc.cz",{"name":155,"role":81,"phone":29,"phoneExt":29,"email":29},{"facility":160,"status":66,"city":161,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Fakultni nemocnice Olomouc","Olomouc",{"type":70,"coordinates":163},[164,165],17.25175,49.59552,{"lat":165,"lon":164},[168,171],{"name":169,"role":60,"phone":29,"phoneExt":29,"email":170},"Ondrej Urban","Ondrej.urban@fnol.cz",{"name":169,"role":81,"phone":29,"phoneExt":29,"email":29},{"facility":173,"status":66,"city":174,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Nemocnice Pardubickeho kraje","Pardubice",{"type":70,"coordinates":176},[177,178],15.77659,50.04075,{"lat":178,"lon":177},[181,184],{"name":182,"role":60,"phone":29,"phoneExt":29,"email":183},"Jiri Drahos","jan.drahos@nempk.cz",{"name":185,"role":81,"phone":29,"phoneExt":29,"email":29},"Petr 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Kralovske Vinohrady",{"type":70,"coordinates":212},[72,73],{"lat":73,"lon":72},[215,218,220],{"name":216,"role":60,"phone":29,"phoneExt":29,"email":217},"Marketa Hlatka","marketa.hlatka@fnkv.cz",{"name":219,"role":81,"phone":29,"phoneExt":29,"email":29},"Martin Oliverius",{"name":221,"role":81,"phone":29,"phoneExt":29,"email":29},"Jan Matous",{"facility":223,"status":66,"city":67,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":224,"geoPoint":226,"contacts":227},"Fakultni Thomayerova nemocnice",{"type":70,"coordinates":225},[72,73],{"lat":73,"lon":72},[228,231],{"name":229,"role":60,"phone":29,"phoneExt":29,"email":230},"Jiri Skopek","jiri.skopek1@ftn.cz",{"name":232,"role":81,"phone":29,"phoneExt":29,"email":29},"Pavel Kohout",{"facility":234,"status":66,"city":67,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":235,"geoPoint":237,"contacts":238},"Institut klinicke a experimentalni mediciny",{"type":70,"coordinates":236},[72,73],{"lat":73,"lon":72},[239,242],{"name":240,"role":60,"phone":29,"phoneExt":29,"email":241},"Tomas Hucl","tomas.hucl@ikem.cz",{"name":240,"role":81,"phone":29,"phoneExt":29,"email":29},{"facility":244,"status":66,"city":67,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":245,"geoPoint":247,"contacts":248},"Vseobecna fakultni nemocnice",{"type":70,"coordinates":246},[72,73],{"lat":73,"lon":72},[249,252],{"name":250,"role":60,"phone":29,"phoneExt":29,"email":251},"Zuzana Namestkova","Zuzana.Namestkova@vfn.cz",{"name":253,"role":81,"phone":29,"phoneExt":29,"email":29},"Michal Vocka",{"facility":255,"status":66,"city":256,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Masarykova nemocnice v Usti nad Labem","Ústí nad Labem",{"type":70,"coordinates":258},[259,260],14.03227,50.6607,{"lat":260,"lon":259},[263,266],{"name":264,"role":60,"phone":29,"phoneExt":29,"email":265},"Jakub Stehlik","Jakub.stehlik@kzcr.eu",{"name":267,"role":81,"phone":29,"phoneExt":29,"email":29},"Jiri Stehlik",{"type":269,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100558331","clinical-performance-of-medical-device-software-lipidica-10-for-processing-data-generated-by-lipidomic-analysis-in-pancreatic-cancer-screening-100558331",false,"NCT06549725","Clinical Performance of Medical Device Software \"Lipidica 1.0\" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening","Inclusion Criteria Arm1:\n\n* Age ≥ 18 years\n* Signed informed consent\n* Histologically confirmed diagnosis of resectable PaC\n\nExclusion Criteria Arm 1:\n\n* History of any other cancer disease\n* Present incurable malignancy\n* Unfit for radical curative resection of the tumor\n* Vegan or vegetarian diet\n\nInclusion Criteria Arm2:\n\n* Age ≥ 18 years\n* Signed informed consent\n* High risk of PaC due to the presence of one of the following risk factors:\n\n  1. Family history of PaC (≥ 2 first-degree or second-degree relatives with PaC in the same family line)\n  2. Confirmed germline mutation of STK11 (LKB1) regardless of family history\n  3. Confirmed germline mutation of CDKN2A leading to the alteration of p16 regardless of family history\n  4. Confirmed germline mutation of APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 AND ≥ 1 first-degree or second-degree relative with PaC\n  5. Present hereditary pancreatitis (recurrent acute pancreatitis or chronic pancreatitis and confirmed germline mutation of PRSS1)\n* Age:\n\n  1. Person with a family history of PaC: \\> 50 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)\n  2. Person with STK11 mutation: \\> 35 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)\n  3. Person with CDKN2A mutation: \\> 40 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)\n  4. Person with APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 mutation: \\> 45 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)\n  5. Person with hereditary pancreatitis: \\> 40 years or 20 years after the 1st attack (whichever comes first)\n\nExclusion Criteria Arm 2:\n\n* Pregnancy of planning to conceive in the next 12 months\n* History of any cancer disease\n* Present incurable malignancy\n* Inability to undergo planned medical imaging or blood sampling\n* Vegan or vegetarian diet",true,"ALL","18 Years",{"count":280,"type":281},419,"ESTIMATED","INTERVENTIONAL",[284],"NA","Software \"Lipidica\" is intended to be used for processing data generated by the in-house in vitro diagnostic medical device for lipidomic testing for the purpose of screening Pancreatic cancer (PaC) in the population at high risk of this cancer due to familial risk, selected gene mutations or hereditary pancreatic diseases.\n\nThe primary objective is to verify that the investigational IVDSW can discriminate between results of patients with Pancreatic cancer and persons without Pancreatic cancer but at higher risk of this cancer disease due to their predispositions.\n\nParticipants will:\n\n* come to baseline and end of study visit for blood sampling and medical imaging\n* some participant will undertake one more visit depending on their results on baseline",[287,288,289,290],"Pancreas Cancer","Pancreatic Ductal Adenocarcinoma","Hereditary Diseases","Pancreatitis, Chronic","2026-04-22",{"date":293,"type":294},"2026-04-27","ACTUAL",{"date":296,"type":294},"2024-09-10",{"date":298,"type":281},"2027-09-26",{"name":5,"class":6},16]