An observational study in Active Tuberculosis, Tuberculosis, Extrapulmonary and Tuberculosis, Pulmonary, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Chinese University of Hong Kong · Observational
Diagnosis and treatment of tuberculosis are often delayed in hospitalized patients, leading to worse outcomes. Rapid diagnosis of tuberculosis currently relies on microscopy and molecular techniques, which have limitations including low sensitivity and high cost.Highly sensitive diagnostic technique is needed for more accurate rapid diagnosis of tuberculosis to aid earlier initiation of antituberculous therapy. Detection of Mycobacterium tuberculosis (MTB) antigens in the bloodstream can potentially allow early diagnosis of tuberculosis. This study aims to evaluate the diagnostic performance of a novel assay using nanotechnology to detect MTB antigens in patients admitted to hospital with suspected pulmonary and/or extrapulmonary tuberculosis. Blood will be taken from eligible patients, and will be sent to the School of Biological and Health Systems Engineering, Arizona State University, for detection of 10-kDa culture filtrate protein (CFP-10) and the 6 kDa early secretory antigenic target (ESAT-6), two antigens specific for MTB, using the Nanodisk-MS assay. Investigations, including microscopy, culture, MTB polymerase chain reaction (PCR), and imaging, will be performed for diagnosis of tuberculosis. The diagnostic performance of Nanodisk-mass spectrometry (MS) assay will be evaluated.
199 studies on the registry are indexed under Latent Tuberculosis; 48 are open to participants now.
This study's enrollment of 100 is below the median of 260 across 82 observational studies indexed under Latent Tuberculosis.
Browse Latent Tuberculosis studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients admitted to the Prince of Wales Hospital and the Alice Ho Miu Ling Nethersole Hospital with suspected pulmonary and extrapulmonary TB will be identified by Infectious Diseases physician and recruited.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Nanodisk-MS assay is a recently reported novel assay for quantitative detection of various MTB antigen peptides, using nanotechnology and mass spectrometry that showed remarkable sensitivity and specificity in diagnosing active pulmonary and extrapulmonary TB. This assay detected MTB-specific antigens, CFP-10 and ESAT-6, in patients' serum samples.
Diagnostic test correlation
Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of Nanodisk-MS assay, in diagnosing "culture-positive" and "culture-negative" pulmonary and/or extrapulmonary TB.
Time frame: One year from the date of recruitment
Ran from Sep 2017 to primary completion in Jul 2019, 22 months.
Of 31 observational studies under Latent Tuberculosis, half reached primary completion within 94 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 98. This study's 22 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese University of Hong Kong →