ObservationNCT02838641
Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB
An observational study of Observation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Observation
- What is being tested?
- GeneXpert
- Type of treatment
- Medical device
- How many people
- 219 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2015to 30 Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced
Who may be able to join
- Patients > 18 years old suspected of TB clinically.
- Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced.
- BAL samples obtained following standard investigation procedure
- CXR or CT imaging available.
Who cannot join
- Bronchoscopy is not planned as a necessary procedure for investigation.
- Diagnosis of active TB has been made by other means.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Shatin
About this study
This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.
- Conditions
- Observation
- Being tested
- GeneXpert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeneXpertDevice
Real time integrated and automated nucleic acid amplification test for detection of TB
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity, specificity, positive and negative predictive values
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startNov 2015
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObservationStudies 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
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, To Kin Wang, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838641
- Sponsor's protocol ID
- 2014.556
- Status last verified
- Apr 2019
- First submitted
- 18 Jul 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB
- ClinicalTrials.gov ID
- NCT02838641
- Acronym / sponsor ID
- 2014.556
- Conditions
- Observation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced
Key inclusion criteria (4 listed)
- Patients > 18 years old suspected of TB clinically.
- Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced.
- BAL samples obtained following standard investigation procedure
- CXR or CT imaging available.
Key exclusion criteria (2 listed)
- Bronchoscopy is not planned as a necessary procedure for investigation.
- Diagnosis of active TB has been made by other means.
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 |
|---|---|---|
| GeneXpertReal time integrated and automated nucleic acid amplification test for detection of TB | Device | – |
Primary outcome
sensitivity, specificity, positive and negative predictive values
Time frame: 18 months
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 17 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Observation, 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 4 inclusion and 2 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 17 Apr 2019. 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?
sensitivity, specificity, positive and negative predictive values (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2019.