[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583362":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":132,"collaborators":136,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":157,"maxAge":10,"enrollmentInfo":158,"targetDuration":10,"studyType":161,"phases":10,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"University of Cologne","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with extrapulmonary tuberculosis",null,"During the visits routine clinical and laboratory parameters (assessment of symptoms e.g. pain, weight gain, blood count, liver enzymes, renal parameters, vitamin D levels, CRP etc.), radiographic imaging (ultrasound, CT scan or MRI) and drug specific parameters (dose, interval, adverse events) are documented. Moreover, 3 sputum specimens (on 3 different days) and 1 urine specimen are collected initially for microscopy, PCR and culture through in-house microbiology departments.\n\nA paper case record form (CRF) will be used to collect patient data, which will be then transferred to an electronic database by local study personnel.\n\nAt each time-point a series of additional specimens, consisting of serum, urine, heparin blood, and PAXgene blood for RNA will be collected and stored. If M. tuberculosis can be cultivated, strains will be stored for genotyping and whole genome sequencing. Serum biomarkers will be tested using commercially available kits.",[13],"Diagnostic Test: biomarker analysis",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","biomarker analysis","PAXgene blood for RNA will be collected and stored. Results from these additional examinations are not included in the treatment monitoring of the patient concerned. If M. tuberculosis can be cultivated, strains will be stored for genotyping and whole genome sequencing. Serum biomarkers will be tested using commercially available kits.\n\nIn addition, TAM-TB assays will be performed from samples stored at each time-point. For this purpose, PBMCs will be collected and frozen using well-established protocols.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Isabelle Suarez, Dr","CONTACT","+49 (221) 478-39680","isabelle.suarez@uk-koeln.de",{"name":27,"role":23,"phone":10,"phoneExt":10,"email":28},"Angela Klingmüller, Dr","angela.klingmueller@uk-koeln.de",[30,51,66,81,98,115],{"facility":31,"status":32,"city":33,"state":10,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"University Hospital Bonn","NOT_YET_RECRUITING","Bonn","53127","Germany","DE",{"type":38,"coordinates":39},"Point",[40,41],7.09549,50.73438,{"lat":41,"lon":40},[44,48],{"name":45,"role":23,"phone":46,"phoneExt":10,"email":47},"Katrin van Bremen, Prof. Dr. med.","+49 (228) 287 19556","Kathrin.vanbremen@ukbonn.de",{"name":49,"role":23,"phone":10,"phoneExt":10,"email":50},"Martha Oberschelp","martha.oberschelp@ukbonn.de",{"facility":52,"status":53,"city":54,"state":10,"zip":55,"country":35,"countryCode":36,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Research Center Borstel","RECRUITING","Borstel","23845",{"type":38,"coordinates":57},[58,59],8.96896,52.67034,{"lat":59,"lon":58},[62],{"name":63,"role":23,"phone":64,"phoneExt":10,"email":65},"Christoph Lange, Prof. Dr. med.","+49-4537-188-6361","clange@fz-borstel.de",{"facility":67,"status":53,"city":68,"state":10,"zip":69,"country":35,"countryCode":36,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University Hospital of Cologne","Cologne","50937",{"type":38,"coordinates":71},[72,73],6.95,50.93333,{"lat":73,"lon":72},[76,78],{"name":77,"role":23,"phone":24,"phoneExt":10,"email":25},"Isabelle Suarez, Dr. med.",{"name":79,"role":23,"phone":24,"phoneExt":10,"email":80},"Jan Rybniker, Dr. med.","jan.rybniker@uk-koeln.de",{"facility":82,"status":32,"city":83,"state":10,"zip":84,"country":35,"countryCode":36,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"University Hospital Frankfurt","Frankfurt","60590 Frankfurt",{"type":38,"coordinates":86},[87,88],10.53333,49.68333,{"lat":88,"lon":87},[91,95],{"name":92,"role":23,"phone":93,"phoneExt":10,"email":94},"Maria Vehreschild, Prof. Dr. med.","+49 (0) 69 6301 7112","maria.vehreschild@kgu.de",{"name":96,"role":23,"phone":93,"phoneExt":10,"email":97},"Nils Wetzstein, Dr.med.","nils.wetzstein@kgu.de",{"facility":99,"status":53,"city":100,"state":10,"zip":101,"country":35,"countryCode":36,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"University Hospital Hamburg","Hamburg","20251 Hamburg",{"type":38,"coordinates":103},[104,105],9.99302,53.55073,{"lat":105,"lon":104},[108,112],{"name":109,"role":23,"phone":110,"phoneExt":10,"email":111},"Marylyn Addo, Prof. Dr. med.","+49 (0)152-22841973","m.addo@uke.de",{"name":113,"role":23,"phone":110,"phoneExt":10,"email":114},"Stefan Schmiedel, Dr. med.","s.schmiedel@uke.de",{"facility":116,"status":53,"city":117,"state":10,"zip":118,"country":35,"countryCode":36,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"University Hospital Heidelberg","Heidelberg","69120",{"type":38,"coordinates":120},[121,122],8.69079,49.40768,{"lat":122,"lon":121},[125,128],{"name":126,"role":23,"phone":10,"phoneExt":10,"email":127},"Claudia Denkinger, Dr. med.","claudia.denkinger@uni-heidelberg.de",{"name":129,"role":23,"phone":130,"phoneExt":10,"email":131},"Stefan Weber, Dr. med.","06221-56-22999","stefan.weber@uni-heidelberg.de",{"type":133,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Isabelle Suarez","Attending Physician",[137,139,140,142,144,145,148],{"name":138,"class":6},"University Hospital, Bonn",{"name":52,"class":6},{"name":141,"class":6},"Johann Wolfgang Goethe University Hospital",{"name":143,"class":6},"Universitätsklinikum Hamburg-Eppendorf",{"name":116,"class":6},{"name":146,"class":147},"Helmholtz Zentrum München","INDUSTRY",{"name":67,"class":6},"100583362","a-multicentric-cohort-and-biomarker-study-for-improved-care-of-patients-with-extrapulmonary-tuberculosis-100583362",false,"NCT06875336","A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis","mEX-TB","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Isolation of Mycobacterium tuberculosis complex from a bodily secretion or tissue by\n\n   1. PCR\n   2. culture or a presumptive clinical diagnosis based on epidemiologic exposure in combination with physical findings, radiographic findings and\u002For histopathology\n3. Patients with extrapulmonary TB\n\n   * pleura\n   * lymph nodes\n   * bones and joints\n   * larynx\n   * pericardial\n   * parotid gland\n   * abdominal sites\n   * kidneys\n   * genitourinary tract\n   * disseminated (miliary) TB\n   * other than pulmonary TB\n4. In the case of pulmonary and extrapulmonary involvement, the leading manifestation, clinically and radiographically, must be extrapulmonary.\n5. Written informed consent provided prior to inclusion\n\nExclusion Criteria:\n\n* 1\\. Age \\\u003C18 years 2. Patient with any social or logistical condition which, as anticipated by the investigator, may interfere with the conduct of the study, such as incapacity to well understand the study content and procedure (in case of any language barriers, a translator may be involved), not willing to collaborate, or anticipated inability to finish study due to physical weakness 3. Dependencies towards the study team (e.g. family members, employees of the same department) 4. Pregnant women 5. Patient in custodianship or guardianship 6. Leading pulmonary manifestation 7. Solitary CNS tuberculosis Patients may take part in other clinical studies and trials, as long as there is no conflict with the inclusion or exclusion criteria of the mEX-TB study and the protocol of the other study or trial does not conflict with the means of data and sample collection and publication of this protocol.","ALL","18 Years",{"count":159,"type":160},150,"ESTIMATED","OBSERVATIONAL","This is a prospective, multicenter, observational study (mEX-TB study) of patients with extrapulmonary tuberculosis (EPTB). Adult patients newly diagnosed with EPTB will prospectively be enrolled into the study. Clinical data will be collected using standardized questionnaires over the whole treatment period for each individual. Additionally, body fluids (blood, urine) will be collected and stored in a central biobank. Biomarkers in EPTB patients will be analyzed during the course of therapy and correlated with clinical data. In addition, a healthy control group will be added, to be used primarily as technical controls for complex laboratory procedures such as RNA-seq and T-cell based assays.",[164],"Extrapulmonary Tuberculosis",[166,167,168],"extrapulmonary tuberculosis","biomarker","cohort study","2025-03-07",{"date":171,"type":172},"2025-03-13","ACTUAL",{"date":174,"type":172},"2023-03-06",{"date":176,"type":160},"2025-12-31",{"name":5,"class":6},6]