Active TuberculosisNCT03271567
Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
An observational study of Active Tuberculosis and Tuberculosis, Extrapulmonary, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Tuberculosis, Tuberculosis, Extrapulmonary, Tuberculosis, Pulmonary
- What is being tested?
- Nanodisk-MS assay
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Sep 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adult patients aged 18 or above,
- Assessed by an Infectious Diseases physician to have clinical and/or radiological suspicion of pulmonary and/or extrapulmonary TB.
Who cannot join
- Refusal to consent from patients or next of kins for incompetent patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Circulating Mycobacterium Tuberculosis Antigen Peptides for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
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.
- Being tested
- Nanodisk-MS assay
- Medical subject headings
- Latent Tuberculosis, Tuberculosis, Extrapulmonary, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanodisk-MS assayDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year from the date of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start28 Sep 2017
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Active TuberculosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Alice Ho Miu Ling Nethersole Hospital
- Responsible party
- Principal investigator, Grace Lui, Chinese University of Hong Kong
- Investigators
- Chung Yan Grace Lui, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271567
- Sponsor's protocol ID
- TB Protocol ver.1
- Status last verified
- Feb 2020
- First submitted
- 1 Sep 2017
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu C, Zhao Z, Fan J, Lyon CJ, Wu HJ, Nedelkov D, Zelazny AM, Olivier KN, Cazares LH, Holland SM, Graviss EA, Hu Y. Quantification of circulating Mycobacterium tuberculosis antigen peptides allows rapid diagnosis of active disease and treatment monitoring. Proc Natl Acad Sci U S A. 2017 Apr 11;114(15):3969-3974. doi: 10.1073/pnas.1621360114. Epub 2017 Mar 27.
PubMed 28348223Lui G, Wong RY, Li F, Lee MK, Lai RW, Li TC, Kam JK, Lee N. High mortality in adults hospitalized for active tuberculosis in a low HIV prevalence setting. PLoS One. 2014 Mar 18;9(3):e92077. doi: 10.1371/journal.pone.0092077. eCollection 2014.
PubMed 24642794
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Circulating Mycobacterium Tuberculosis Antigen Peptides for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT03271567
- Acronym / sponsor ID
- TB Protocol ver.1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Alice Ho Miu Ling Nethersole Hospital
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Adult patients aged 18 or above,
- Assessed by an Infectious Diseases physician to have clinical and/or radiological suspicion of pulmonary and/or extrapulmonary TB.
Key exclusion criteria (1 listed)
- Refusal to consent from patients or next of kins for incompetent patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanodisk-MS assayNanodisk-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 | – |
Primary outcome
Diagnostic test correlation
Time frame: One year from the date of recruitment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Background: PubMed 28348223Liu C, Zhao Z, Fan J, Lyon CJ, Wu HJ, Nedelkov D, Zelazny AM, Olivier KN, Cazares LH, Holland SM, Graviss EA, Hu Y. Quantification of circulating Mycobacterium tuberculosis antigen peptides allows rapid diagnosis of active disease and treatment monitoring. Proc Natl Acad Sci U S A. 2017 Apr 11;114(15):3969-3974. doi: 10.1073/pnas.1621360114. Epub 2017 Mar 27.
- Background: PubMed 24642794Lui G, Wong RY, Li F, Lee MK, Lai RW, Li TC, Kam JK, Lee N. High mortality in adults hospitalized for active tuberculosis in a low HIV prevalence setting. PLoS One. 2014 Mar 18;9(3):e92077. doi: 10.1371/journal.pone.0092077. eCollection 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung Yan Grace Lui principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Active Tuberculosis and Tuberculosis, Extrapulmonary, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic test correlation (time frame: One year from the date of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03271567, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.