[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583206":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":143,"collaborators":145,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":151,"sex":157,"minAge":158,"maxAge":19,"enrollmentInfo":159,"targetDuration":19,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"IRCCS Sacro Cuore Don Calabria di Negrar","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Participants","All eligible participants identified as having chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory assessment at enrollment that will include blood sampling for hematology, Schistosoma serology available at each site, and PCR for Schistosoma where available; urine sampling for microscopy, determination of hematuria as indirect markers of schistosomiasis morbidity, and Schistosoma PCR (where available) and POC-CCA urine strip assay (where available); and stool sampling for microscopy and PCR where available, and fecal occult blood as indirect markers of schistosomiasis morbidity. Serum (at least 1 mL leftover from routine diagnostics) will be sent to LUMC, Netherlands, where CAA will be determined with the UCP-LF CAA assay (dry format) designed for routine use.",[12],"Device: UCP-LF CAA assay",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","UCP-LF CAA assay","dry LF-CAA, or CAA",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Federico Giovanni Gobbi","IRCCS Sacro Cuore Don Calabria","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Elvia Malo","CONTACT","+390456013111","ricerca.clinica@sacrocuore.it",[32,48,63,78,91,103,117,131],{"facility":33,"status":34,"city":35,"state":19,"zip":19,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Institute of Tropical Medicine (ITM)","RECRUITING","Antwerp","Belgium","BE",{"type":39,"coordinates":40},"Point",[41,42],4.40026,51.22047,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":19,"phoneExt":19,"email":47},"Emmanuel Bottieau","EBottieau@itg.be",{"facility":49,"status":50,"city":51,"state":19,"zip":19,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Universitätsklinikum Hamburg-Eppendorf","NOT_YET_RECRUITING","Hamburg","Germany","DE",{"type":39,"coordinates":55},[56,57],9.99302,53.55073,{"lat":57,"lon":56},[60],{"name":61,"role":28,"phone":19,"phoneExt":19,"email":62},"Sabine Jordan","s.jordan@uke.de",{"facility":64,"status":34,"city":65,"state":66,"zip":19,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"IRCCS Policlinico Sant'Orsola","Bologna","BO","Italy","IT",{"type":39,"coordinates":70},[71,72],11.33875,44.49381,{"lat":72,"lon":71},[75],{"name":76,"role":28,"phone":19,"phoneExt":19,"email":77},"Bianca Granozzi","bianca.granozzi@aosp.bo.it",{"facility":23,"status":34,"city":79,"state":80,"zip":81,"country":67,"countryCode":68,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Negrar","VR","37024",{"type":39,"coordinates":83},[84,85],10.93899,45.52918,{"lat":85,"lon":84},[88],{"name":22,"role":28,"phone":89,"phoneExt":19,"email":90},"+39(0)456013111","federico.gobbi@sacrocuore.it",{"facility":92,"status":50,"city":93,"state":19,"zip":19,"country":67,"countryCode":68,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"AOU Careggi","Florence",{"type":39,"coordinates":95},[96,97],11.24626,43.77925,{"lat":97,"lon":96},[100],{"name":101,"role":28,"phone":19,"phoneExt":19,"email":102},"Lorenzo Zammarchi","lorenzo.zammarchi@unifi.it",{"facility":104,"status":50,"city":105,"state":19,"zip":19,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Medical Microbiology & Infectious Diseases, Erasmus MC","Rotterdam","Netherlands","NL",{"type":39,"coordinates":109},[110,111],4.47917,51.9225,{"lat":111,"lon":110},[114],{"name":115,"role":28,"phone":19,"phoneExt":19,"email":116},"Jaap van Hellemond","j.vanhellemond@erasmusmc.nl",{"facility":118,"status":34,"city":119,"state":19,"zip":19,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Tropical Medicine Unit of Hospital de Poniente","Almería","Spain","ES",{"type":39,"coordinates":123},[124,125],-2.45974,36.83814,{"lat":125,"lon":124},[128],{"name":129,"role":28,"phone":19,"phoneExt":19,"email":130},"Joaquin Salas Coronas","joaquinsalascoronas@yahoo.es",{"facility":132,"status":34,"city":133,"state":19,"zip":19,"country":120,"countryCode":121,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Vall d'Hebron University Hospital","Barcelona",{"type":39,"coordinates":135},[136,137],2.15899,41.38879,{"lat":137,"lon":136},[140],{"name":141,"role":28,"phone":19,"phoneExt":19,"email":142},"Fernando Salvador Velez","fernando.salvador@vallhebron.cat",{"type":144,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[146],{"name":147,"class":148},"Leiden University Medical Center (LUMC)","UNKNOWN","100583206","assessment-of-infection-activity-in-travelers-and-migrants-diagnosed-with-chronic-schistosomiasis-100583206",false,"NCT06873308","Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis","Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis: a Multicentric Prospective Cohort Study","SchistAct","Inclusion criteria\n\n1. diagnosis of chronic schistosomiasis (\\>3 months after last potential exposure) according to site-specific diagnostic practice\n2. signed informed consent (and assent for minors).\n\nExclusion criteria\n\n1. age below 5 years;\n2. exposure to praziquantel after the last potential exposure to schistosomes\n3. acute infection, i.e. likely infection \\\u003C3 months before presentation","ALL","5 Years",{"count":160,"type":161},278,"ESTIMATED","INTERVENTIONAL",[164],"NA","The primary objective of this clinical investigation is to determine the percentage of travelers and migrants diagnosed with chronic schistosomiasis according to site-specific diagnostic practice who have active infection at the time of evaluation (as assessed and classified by composite reference standards that integrate clinical, laboratory, and diagnostic features, such as microscopy, PCR (where available), POC-CCA (where available), and serum CAA results).\n\nAll subjects with chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory evaluation at the time of evaluation that will include blood sampling for hematology, schistosome serology available at each site, and schistosome PCR where available; urine sampling for microscopy, determination of hematuria as an indirect marker of morbidity for schistosomiasis, and Schistosome PCR (where available), and urine strip testing POC-CCA (where available); and stool sampling for microscopy and PCR, where available, and fecal occult blood as indirect markers of schistosomiasis morbidity.\n\nComposite reference standards will be used to assess and classify the activity of the infection. Organ-specific ultrasound and other tests will be left to the physician's decision, but results will also be collected.\n\nSerum (at least 1 ml remaining from routine diagnostics) will be sent to LUMC, the Netherlands, where CAA will be determined with the UCP-LF CAA test designed for routine use.\n\nParticipants will be asked to sign an additional consent form, which is optional and not precluding enrollment in the study, to allow the remaining serum to be stored at LUMC for 15 years, to allow secondary research.",[167],"Schistosomiasis",[169,170,171],"schistosomiasis","chronic","diagnosis","2025-04-16",{"date":174,"type":175},"2025-04-20","ACTUAL",{"date":177,"type":175},"2024-06-28",{"date":179,"type":161},"2027-01",{"name":5,"class":6},8]