[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602573":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":45,"studyPopulation":49,"armGroups":50,"interventions":58,"overallOfficials":64,"centralContacts":75,"locations":85,"responsibleParty":102,"collaborators":45,"id":106,"slug":45,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":45,"enrollmentInfo":115,"targetDuration":45,"studyType":118,"phases":45,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":87,"whyStopped":45,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Research Center Borstel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":34,"otherOutcomes":45},[9,13,16,19,22,25,28,31],{"measure":10,"description":11,"timeFrame":12},"Feasibility of biomarker-guided diagnosis of TB - mRNA signatures","Assessment of the feasibility of tuberculosis (TB) diagnostics based on mRNA signatures.","From enrollment to the end of the first week of treatment",{"measure":14,"description":15,"timeFrame":12},"Feasibility of biomarker-guided diagnosis of TB - cellular immunology","Assessment of the feasibility of tuberculosis (TB) diagnostics based on cellular immunology.",{"measure":17,"description":18,"timeFrame":12},"Feasibility of biomarker-guided diagnosis of TB - PATHFAST-LAM","Assessment of the feasibility of tuberculosis (TB) diagnostics based on PATHFAST-LAM.",{"measure":20,"description":21,"timeFrame":12},"Feasibility of biomarker-guided diagnosis of TB - EclLAM","Assessment of the feasibility of tuberculosis (TB) diagnostics based on EclLAM assays.",{"measure":23,"description":24,"timeFrame":12},"Feasibility of biomarker-guided diagnosis of TB - cell-free Mycobacterium tuberculosis DNA","Assessment of the feasibility of tuberculosis (TB) diagnostics based on cell-free Mycobacterium tuberculosis DNA.",{"measure":26,"description":27,"timeFrame":12},"Feasibility of biomarker-guided diagnosis of TB - MBLA","Assessment of the feasibility of tuberculosis (TB) diagnostics based on Mycobacterial Load Assay (MBLA).",{"measure":29,"description":30,"timeFrame":12},"Feasibility of biomarker-guided diagnosis of TB - stool PCR","Assessment of the feasibility of tuberculosis (TB) diagnostics based on stool PCR testing.",{"measure":32,"description":33,"timeFrame":12},"Feasibility of biomarker-guided diagnosis of TB - composit","Assessment of the feasibility of tuberculosis (TB) diagnostics based on a combination of mRNA signatures, cellular immunology, PATHFAST-LAM and EclLAM assays, cell-free Mycobacterium tuberculosis DNA analysis, MBLA, stool PCR testing, and QuantiFERON®-TB Gold Plus testing.",[35,39,41,43],{"measure":36,"description":37,"timeFrame":38},"Exploratory Analysis of Biomarker Profiles and Their Clinical Associations","Degree of correlation between the different biomarkers.","From enrollment to the end of the first week of treatment.",{"measure":36,"description":40,"timeFrame":38},"Qualitative and quantitative characterization of differences in biomarker profiles between pulmonary and extrapulmonary tuberculosis.",{"measure":36,"description":42,"timeFrame":38},"Qualitative and quantitative characterization of sex-specific differences in biomarker expression patterns.",{"measure":36,"description":44,"timeFrame":38},"Degree of correlation between biomarkers and disease severity, as well as their potential prognostic value.",null,{"allocation":45,"interventionModel":45,"interventionModelDescription":45,"primaryPurpose":45,"observationalModel":47,"timePerspective":48,"maskingInfo":45},"COHORT","PROSPECTIVE","Patients \\> 18 years of age, including women of childbearing potential with or without contraception. Only adult patients capable of giving informed consent will be included; obtaining consent from legal guardians is not planned.",[51,55],{"label":52,"type":45,"description":45,"interventionNames":53},"Patients with suspected TB",[54],"Diagnostic Test: Biomarker-guided diagnostic tests",{"label":56,"type":45,"description":45,"interventionNames":57},"Other pulmonary infections (control group)",[54],[59],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":45},"DIAGNOSTIC_TEST","Biomarker-guided diagnostic tests","mRNA-Signature from blood; immunophenotyping from blood; MBLA from sputum, PATHFAST-LAM and EclLAM from sputum, stool, urine; CRISPR-Cas from blood; stool PCR; QuantiFERON(R)-TB Gold Plus.",[56,52],[65,69,72],{"name":66,"affiliation":67,"role":68},"Christoph Lange, Prof. Dr. Dr. h.c.","Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center","STUDY_CHAIR",{"name":70,"affiliation":71,"role":68},"Marylyn Martina Addo, Prof. Dr.","Institute for Infection Research and Vaccine Development, University Medical Center Hamburg-Eppendorf",{"name":73,"affiliation":74,"role":68},"Stefan Schmiedel, Dr. med.","Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany",[76,81],{"name":77,"role":78,"phone":79,"phoneExt":45,"email":80},"Thomas Theo Brehm, Dr. med.","CONTACT","+49 4537 188 2905","tbrehm@fz-borstel.de",{"name":82,"role":78,"phone":83,"phoneExt":45,"email":84},"Niklas Köhler, Dr. med.","+49 4537 188 8080","nkoehler@fz-borstel.de",[86],{"facility":74,"status":87,"city":88,"state":45,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"RECRUITING","Hamburg","20246","Germany","DE",{"type":93,"coordinates":94},"Point",[95,96],9.99302,53.55073,{"lat":96,"lon":95},[99],{"name":77,"role":78,"phone":100,"phoneExt":45,"email":101},"+49 152 2282 3999","t.brehm@uke.de",{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"PRINCIPAL_INVESTIGATOR","Thomas Theo Brehm","Dr. med.","100602573",false,"NCT07125274","Sputum-free Diagnostis of TB","Biomarker-guided Diagnosis of Tuberculosis","TB_Diagnostics","Inclusion Criteria:\n\n* Suspected pulmonary or extrapulmonary tuberculosis, or confirmed pulmonary or extrapulmonary tuberculosis with less than 7 days of anti-tuberculosis treatment, OR other pulmonary infection (control group).\n* Age ≥ 18 years\n* Ability to provide informed consent\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Lack of ability to provide informed consent\n* Age \\\u003C 18 years\n* Pregnancy","ALL","18 Years",{"count":116,"type":117},100,"ESTIMATED","OBSERVATIONAL","The aim of this study is to identify new biomarkers that enable reliable, non-invasive diagnosis of tuberculosis (TB), including in patients who are unable to produce sputum. The study analyzes biomaterials (blood, urine, stool, sputum) collected from patients with suspected TB. Various diagnostic methods are applied to assess the feasibility of individual and combined biomarker tests.\n\nParticipating patients will provide biomaterial samples (blood, urine, stool, sputum) once. No additional examinations or invasive procedures will be performed. Routine diagnostic procedures remain unaffected.\n\nThis is a single-center, prospective observational study. Patients are enrolled as part of their clinical care at the University Medical Center Hamburg-Eppendorf.",[121],"Tuberculosis",[123,124,125,126,127,128,129,130,131],"TB","diagnostics","sputum","sputum-free","transcriptomic","pathfast","CRISPR","stool","PCR","2025-08-12",{"date":134,"type":135},"2025-08-15","ACTUAL",{"date":137,"type":135},"2025-06-06",{"date":139,"type":117},"2026-12",{"name":5,"class":6},1]