[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557408":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":36,"centralContacts":40,"locations":48,"responsibleParty":75,"collaborators":10,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":10,"enrollmentInfo":88,"targetDuration":10,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":10,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Zurich","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"No invasive fungal disease",null,"Patients, that retrospectively do not have evidence of IFI",[13],"Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)",{"label":15,"type":10,"description":16,"interventionNames":17},"Possible invasive fungal disease","Patients, that retrospectively have a possible IFI (according to EORTC guidelines). There is suspicion of IFI by clinical or radiological features, but no microbiological evidence of IFI.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Probable invasive fungal disease","Patients, that retrospectively have a probable IFI (according to EORTC guidelines). There is suspicion of IFI by clinical or radiological features, and indirect microbiological evidence of IFI.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Proven invasive fungal disease","Patients, that retrospectively have a proven IFI (according to EORTC guidelines). There is histological (angioinvasive growth of a fungus) or definitive microbiological evidence of IFI, e.g. evidence of a fungus from a sterile tissue.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIAGNOSTIC_TEST","Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)","Identify volatile biomarkers of IFI by analyzing the breath metabolome of patients with proven or probable IFI according to the criteria outlined by EORTC\u002FMSG and controls.",[9,15,19,23],[33,34,35],"Blood sampling (serologic biomarkers, PCR)","Sputum analysis","Low-dose CT",[37],{"name":38,"affiliation":5,"role":39},"Jeremy Deuel, PD Dr.","PRINCIPAL_INVESTIGATOR",[41,45],{"name":38,"role":42,"phone":43,"phoneExt":10,"email":44},"CONTACT","+41 44 255 11 11","jeremy.deuel@usz.ch",{"name":46,"role":42,"phone":43,"phoneExt":10,"email":47},"Kevin Hofer, Dr.","kevin.hofer@usz.ch",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University Hospital of Zurich","RECRUITING","Zurich","Canton of Zurich","8091","Switzerland","CH",{"type":58,"coordinates":59},"Point",[60,61],8.55,47.36667,{"lat":61,"lon":60},[64,67,68,69,71,73],{"name":65,"role":42,"phone":66,"phoneExt":10,"email":44},"Jeremy Deuel, PD Dr. Dr.","+41442551111",{"name":46,"role":42,"phone":66,"phoneExt":10,"email":47},{"name":38,"role":39,"phone":10,"phoneExt":10,"email":10},{"name":46,"role":70,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":72,"role":70,"phone":10,"phoneExt":10,"email":10},"Noriane Sievi",{"name":74,"role":70,"phone":10,"phoneExt":10,"email":10},"Egli Adrian, Prof. Dr.",{"type":39,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jeremy Deuel","Principal Investigaor","100557408","breath-analysis-for-the-detection-of-invasive-fungal-infections-100557408",false,"NCT06537726","Breath Analysis for the Detection of Invasive Fungal Infections","Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients","REDEFINE","Inclusion Criteria:\n\n* Diagnosis of acute leukemia\n* Planned chemotherapy with a duration of hospitalisation of 2 weeks or longer\n* Neutropenia (\\\u003C500\u002Fµl) present at inclusion or planned chemotherapy with expected neutropenia (\\\u003C500\u002Fµl) for more than 7 days\n\nExclusion Criteria:\n\n* Unable to follow instructions for breath analysis\n* Anatomic abnormalities precluding the use of a mouthpiece for breath analysis","ALL","18 Years",{"count":89,"type":90},130,"ESTIMATED","OBSERVATIONAL","Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity.\n\nWith the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).",[94,95,96,97,98,99,100],"Leukemia","Leukemia, Myeloid","Leukemia, Lymphoblastic","Neutropenia","Chemotherapy-induced Neutropenia","Invasive Fungal Infections","Invasive Pulmonary Aspergillosis","2025-04-09",{"date":103,"type":104},"2025-04-10","ACTUAL",{"date":106,"type":104},"2024-08-19",{"date":108,"type":90},"2027-10-31",{"name":5,"class":6},1]