[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610659":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":63,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":71,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PTB",null,"Patients with pulmonary tuberculosis",[13],"Diagnostic Test: Diagnostic Test: Plasma MTB cfDNA assay",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-PTB","Patients without pulmonary tuberculosis",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Diagnostic Test: Plasma MTB cfDNA assay","Quantitative measurement of MTB cfDNA level in the plasma",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Ka Pang Chan, MBChB","CONTACT","35052211","chankapang@cuhk.edu.hk",[31],{"facility":32,"status":10,"city":33,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Prince of Wales Hospital","Hong Kong","HK",{"type":36,"coordinates":37},"Point",[38,39],114.17469,22.27832,{"lat":39,"lon":38},[42,43],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"name":44,"role":27,"phone":45,"phoneExt":10,"email":46},"Karen Yiu","35053532","ysyiu@cuhk.edu.hk",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Ka Pang Chan","Assistant Professor","100610659","plasma-mtb-cfdna-before-bronchoscopy-100610659",false,"NCT07230457","Plasma MTB cfDNA Before Bronchoscopy","Prospective Evaluation of Plasma Mycobacterium Tuberculosis Cell-free DNA Sequencing as a Non-Invasive Alternative to Bronchoscopy for Diagnosing Pulmonary Tuberculosis","Inclusion Criteria:\n\n* Aged 18 years or above\n* Presence of respiratory indication requiring bronchoscopy\n* Sputum AFB smear negative or unable to expectorate sputum for investigations\n\nExclusion Criteria:\n\n* BALF collected but not sent for MTB PCR\n* History of PTB or EPTB\n* Concomitant use of at least two anti-TB medications for more than 14 consecutive days in the past 3 months\n* Repeated bronchoscopy in the same subject within the study period\n* Expected survival of less than 12 months from a different pathology\n* Use of unregistered therapeutic agents in the 30 days before the study\n* Consent not obtained from the subjects","ALL","18 Years",{"count":61,"type":62},600,"ESTIMATED","12 Months","OBSERVATIONAL","Tuberculosis (TB) remains a major global health challenge, affecting over 10 million people annually. Hong Kong carries an intermediate TB burden, with \\~3,200 new cases reported yearly. Pulmonary TB (PTB), the most common form, presents diagnostic difficulties. Traditional methods like sputum smear and culture often fail in patients unable to produce adequate samples, necessitating bronchoscopy to collect bronchoalveolar lavage (BAL) for mycobacterial testing.\n\nThese limitations pose risks for patients and strain healthcare systems. Bronchoscopy is invasive, resource-intensive, and may delay treatment-especially for elderly patients with comorbidities. Blood-based inflammatory markers lack diagnostic specificity. A rapid, non-invasive alternative is urgently needed.\n\nThe investigators developed a plasma-based assay that detects Mycobacterium tuberculosis cell-free DNA (MTB cfDNA) in blood. This liquid biopsy leverages metagenomic sequencing and computational analysis to identify TB-specific genetic material while minimizing contamination. Preliminary data show excellent diagnostic performance, with area under the receiver operating characteristic curve values \\>0.94 for TB pleurisy.\n\nThe investigators propose a prospective clinical validation study comparing plasma MTB cfDNA testing to bronchoscopy with BAL culture and molecular testing. The primary aim is to demonstrate non-inferiority of plasma cfDNA within a 10% sensitivity margin. Secondary aims include assessing how clinical and radiological features affect test performance and evaluating the assay's ability to detect drug resistance mutations for personalized therapy.\n\nValidation could transform TB diagnosis by offering a rapid, safe, and accurate blood test. Patients could avoid invasive procedures, receive faster diagnoses, and begin treatment sooner. Detecting resistance mutations directly from plasma would enable timely, targeted therapy-critical for addressing multidrug-resistant TB. This represents a paradigm shift toward precision medicine in TB care.\n\nTailored to Hong Kong's epidemiological context, this study addresses a key diagnostic gap. The approach has global relevance, with potential to improve clinical outcomes, reduce costs, and accelerate progress toward WHO's TB elimination goals.",[67],"Tuberculosis Diagnosis",[69,70],"Pulmonary tuberculosis","Cell-free DNA","NOT_YET_RECRUITING","2025-11-13",{"date":74,"type":75},"2025-11-17","ACTUAL",{"date":77,"type":62},"2026-10-01",{"date":79,"type":62},"2029-06-30",{"name":5,"class":6},1]