Tuberculosis InfectionNCT04148053
Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis
An observational study of Tuberculosis Infection, run by Tongji University at 1 site in China.
Trial summary
Diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China. This observational study aims to evaluate TB-antigen responsive T cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt… Read more about this study
- Who is it for?
- Ages 7 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis Infection
- What is being tested?
- TB-antigen responsive T cell markers
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 1 Mar 2020
- 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 7 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any patients suspicious of TB infection
Who may be able to join
- any patients suspicious of TB infection
- TB culture and Xpert test required
- Chest X-ray required
Who cannot join
- anti-TB therapy before the sample collection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200123
BO SU, Dr., 86-021-65115006 ext. 3039, su_bo_s@hotmail.com
Bo SU, DR
About this study
Official title: Evaluation of TB-antigen Responsive T Cell Markers in Diagnosis of Tuberculosis and Extrapulmonary Tuberculosis
Diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China. This observational study aims to evaluate TB-antigen responsive T cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt and cost-effective laboratory tests for active TB screening.
Read the detailed description
The enrolled patients will be grouped into active or latent tuberculosis according to the bacteriological evidence of TB. The TB-antigen responsive T cell markers will be examined. The performance of each T cell marker for the diagnosis of active TB will be systematically evaluated.
- Conditions
- Tuberculosis Infection
- Being tested
- TB-antigen responsive T cell markers
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB-antigen responsive T cell markersDiagnostic test
A blood test including a series of T cell markers which are responsive to TB antigens
| Study group | Role | What they receive |
|---|---|---|
| Active TB | Subjects met the following:
1. Either Pulmonary or Extra-pulmonary tuberculosis patients
2. TB Bacteriological evidence obtained by culture or Xpert MTB/RIF from at least 1 specimen. Receives: Diagnostic Test: TB-antigen responsive T cell markers | |
| Latent TB | Subjects met the following:
1. TB Contact in history.
2. Chest X-ray suggestive of non-TB.
3. without any symptoms suggestive of TB.
4. TST and/or IGRA positive. Receives: Diagnostic Test: TB-antigen responsive T cell markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive rate and negative rate
Evaluation of the positive rate and negative rate for each T cell marker
Measured: 2-3 month after sampling
Receiver operating characteristic curve
The AUC of each T cell marker will be analyzed and compared
Measured: 2-3 month after sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Nov 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148053
- Sponsor's protocol ID
- CTB18001
- Status last verified
- Oct 2019
- First submitted
- 29 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sharing of individual participant data will be decided by the sponsor after the accomplishment of the study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TB-antigen Responsive T Cell Markers in Diagnosis of Tuberculosis and Extrapulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT04148053
- Acronym / sponsor ID
- CTB18001
- Conditions
- Tuberculosis Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 1 Nov 2019 (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 of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China. This observational study aims to evaluate TB-antigen responsive T cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt and cost-effective laboratory tests for active TB screening.
Detailed description
The enrolled patients will be grouped into active or latent tuberculosis according to the bacteriological evidence of TB. The TB-antigen responsive T cell markers will be examined. The performance of each T cell marker for the diagnosis of active TB will be systematically evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TB | – | Diagnostic Test: TB-antigen responsive T cell markersSubjects met the following: 1. Either Pulmonary or Extra-pulmonary tuberculosis patients 2. TB Bacteriological evidence obtained by culture or Xpert MTB/RIF from at least 1 specimen. |
| Latent TB | – | Diagnostic Test: TB-antigen responsive T cell markersSubjects met the following: 1. TB Contact in history. 2. Chest X-ray suggestive of non-TB. 3. without any symptoms suggestive of TB. 4. TST and/or IGRA positive. |
Who may qualify
- Ages
- 7 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients suspicious of TB infection
Key inclusion criteria (3 listed)
- any patients suspicious of TB infection
- TB culture and Xpert test required
- Chest X-ray required
Key exclusion criteria (1 listed)
- anti-TB therapy before the sample collection.
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 |
|---|---|---|
| TB-antigen responsive T cell markersA blood test including a series of T cell markers which are responsive to TB antigens | Diagnostic test | Active TB, Latent TB |
Primary outcome
Positive rate and negative rate
Time frame: 2-3 month after sampling
Evaluation of the positive rate and negative rate for each T cell marker
Receiver operating characteristic curve
Time frame: 2-3 month after sampling
The AUC of each T cell marker will be analyzed and compared
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: Undecided. The sharing of individual participant data will be decided by the sponsor after the accomplishment of the study.
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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.
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 Tuberculosis Infection, run by Tongji University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Nov 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BO SU, Dr (86-021-65115006 ext. 3039, su_bo_s@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive rate and negative rate (time frame: 2-3 month after sampling). The study lists 2 primary outcomes in all. 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 1 Nov 2019.