Tuberculosis (TB)NCT06796647
ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients
An observational study of Tuberculosis (TB), run by Chinese University of Hong Kong at 2 sites in 2 countries.
Trial summary
The aim of the study is to pilot the application of a novel ESAT6/CFP10 (C-TST) skin test in rheumatologic disease patients prior to initiation of treatment with biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis (TB)
- What is being tested?
- ESAT6/CFP10 skin test
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Mar 2025to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatology patients followed up at the Specialist Services of regional hospitals in New Territories East Cluster in Hong Kong (Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and North District Hospital)
Who may be able to join
- adult of age ≥ 18 and up to 65 years;
- diagnosis of at least one classified rheumatologic disease; and
- being planned to receive b/tsDMARDs therapy,
- can communicate in Chinese and/or English.
Who cannot join
- diagnosis of active TB diseases,
- currently receiving TB or LTBI treatment;
- concurrent mental illnesses;
- prisoners.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
S.H. Ho Research Centre for Infectious Diseases
Hong Kong, Hong Kong, 0000
Shui Shan Lee, MD, 852-61703177, sslee.ss@gmail.com
Ho So, FRCP, 852-35053139
Hong Kong1 site, 1 recruiting
- Not yet recruiting
S.H. Ho Research Centre for Infectious Diseases
Shatin, Hong Kong, 0000
Shui Shan Lee, MD, 852 22528812, sslee@cuhk.edu.hk
Ho So, FRCP, 852 3505 3139, hoso@cuhk.edu.hk
About this study
Official title: The Use of a Novel ESAT6/CFP10 Skin Test in Diagnosis of Latent Tuberculosis Infection Among Rheumatologic Patients
The aim of the study is to pilot the application of a novel ESAT6/CFP10 (C-TST) skin test in rheumatologic disease patients prior to initiation of treatment with biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD). This is a prospective observational study involving the recruitment of patients with rheumatologic diseases who are planned for initiation of b/tsDMARD. Eligible patients would undergo skin testing by the Mantoux technique with purified protein derivative (PPD) RT23 on one forearm and C-TST on the other, alongside routine blood sampling for Interferon-Gamma Release Assay. The skin test results would be read within 48-72 hours afterwards. Treatment of TB infection would be provided in accordance with current clinical guidelines, followed by regular clinical monitoring for 2 years. Analyses involve performance evaluation of C-TST, and decision-analytical modelling incorporating multiple Markov process to evaluate the impact of management by LTBI testing methods on clinical outcomes and health care costs.
Read the detailed description
Objective. The aim of the study is to pilot the application of a novel ESAT6/CFP10 (C-TST) skin test in rheumatologic disease patients prior to initiation of treatment with biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD), with the objectives of determining its performance and the cost-effectiveness of clinical management for latent tuberculosis infection (LTBI).
Design. A prospective observational study
Setting. Rheumatology Specialist clinic services in Hong Kong
Methods. This study involves the recruitment of patients with rheumatologic diseases who are planned for initiation of b/tsDMARD. Eligible patients would undergo skin testing by the Mantoux technique with intradermal injection of 2U purified protein derivative (PPD) RT23 on one forearm and 5U of C-TST on the other, alongside routine blood sampling for Interferon-Gamma Release Assay (IGRA) with QuantiFERON-TB Gold. The skin test results would be read within 48-72 hours afterwards. Treatment of LTBI would be provided in accordance with current clinical guidelines, followed by regular clinical monitoring for 2 years. Analyses involve performance evaluation of C-TST, and decision-analytical modelling incorporating multiple Markov process to evaluate the impact of management by LTBI testing methods on clinical outcomes and health care costs.
Main outcome measures. Concordance between different tests for LTBI by Kappa measure; sensitivity and specificity of C-TST test estimated with current standard; proportion of new TB cases averted, discounted QALYG and ICER.
Anticipated outcome. The study would provide preliminary evidence regarding the diagnostic performance of C-TST, and impact of its utilisation for treatment decision for rheumatologic diseases patients in the prevention of active tuberculosis diseases.
- Conditions
- Tuberculosis (TB)
- Being tested
- ESAT6/CFP10 skin test
- Keywords
- tuberculosis, skin testing, ESAT6/CFP10, rheumatology patients
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESAT6/CFP10 skin testDiagnostic test
Each recruited participant would be offered standard tuberculin skin test (TST) and ESAT6/CFP10 (C-TST) skin test on the same day or setting of clinical visit. TST and C-TST would be performed by the Mantoux technique with intradermal injection of 2U purified protein derivative-RT23 on one forearm and 5U (1.0µg/0.1 ml) of recombinant fusion protein ESAT6-CFP10 on the other forearm respectively.
| Study group | Role | What they receive |
|---|---|---|
| study group | Adult patients with diagnosed rheumatologic diseases scheduled to receive b/tsDMARDs therapy Receives: Diagnostic Test: ESAT6/CFP10 skin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-TST reading
Concordance between C-TST and standard TST
Measured: from enrolment to reading test result at 48-72 hours
C-TST reading
Concordance between C-TST and IGRA test result
Measured: from enrolment to reading test result at 2 weeks
Secondary outcomes (1)
Proportion with TB disease
Proportion of patients by test results who developed TB disease
Measured: from enrolment to last followup at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start19 Mar 2025
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shui-Shan Lee, MD, Chinese University of Hong Kong
- Investigators
- David SC Hui, MD, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796647
- Sponsor's protocol ID
- HMRF23220212
- Status last verified
- Sep 2025
- First submitted
- 22 Jan 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access of individual level data at individual level is restricted for protection of privacy, as stipulated in the institutional approval
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Novel ESAT6/CFP10 Skin Test in Diagnosis of Latent Tuberculosis Infection Among Rheumatologic Patients
- ClinicalTrials.gov ID
- NCT06796647
- Acronym / sponsor ID
- HMRF23220212
- Conditions
- Tuberculosis (TB)
- Keywords
- tuberculosis, skin testing, ESAT6/CFP10, rheumatology patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Jan 2025 (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.
The aim of the study is to pilot the application of a novel ESAT6/CFP10 (C-TST) skin test in rheumatologic disease patients prior to initiation of treatment with biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD). This is a prospective observational study involving the recruitment of patients with rheumatologic diseases who are planned for initiation of b/tsDMARD. Eligible patients would undergo skin testing by the Mantoux technique with purified protein derivative (PPD) RT23 on one forearm and C-TST on the other, alongside routine blood sampling for Interferon-Gamma Release Assay. The skin test results would be read within 48-72 hours afterwards. Treatment of TB infection would be provided in accordance with current clinical guidelines, followed by regular clinical monitoring for 2 years. Analyses involve performance evaluation of C-TST, and decision-analytical modelling incorporating multiple Markov process to evaluate the impact of management by LTBI testing methods on clinical outcomes and health care costs.
Detailed description
Objective. The aim of the study is to pilot the application of a novel ESAT6/CFP10 (C-TST) skin test in rheumatologic disease patients prior to initiation of treatment with biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD), with the objectives of determining its performance and the cost-effectiveness of clinical management for latent tuberculosis infection (LTBI).
Design. A prospective observational study
Setting. Rheumatology Specialist clinic services in Hong Kong
Methods. This study involves the recruitment of patients with rheumatologic diseases who are planned for initiation of b/tsDMARD. Eligible patients would undergo skin testing by the Mantoux technique with intradermal injection of 2U purified protein derivative (PPD) RT23 on one forearm and 5U of C-TST on the other, alongside routine blood sampling for Interferon-Gamma Release Assay (IGRA) with QuantiFERON-TB Gold. The skin test results would be read within 48-72 hours afterwards. Treatment of LTBI would be provided in accordance with current clinical guidelines, followed by regular clinical monitoring for 2 years. Analyses involve performance evaluation of C-TST, and decision-analytical modelling incorporating multiple Markov process to evaluate the impact of management by LTBI testing methods on clinical outcomes and health care costs.
Main outcome measures. Concordance between different tests for LTBI by Kappa measure; sensitivity and specificity of C-TST test estimated with current standard; proportion of new TB cases averted, discounted QALYG and ICER.
Anticipated outcome. The study would provide preliminary evidence regarding the diagnostic performance of C-TST, and impact of its utilisation for treatment decision for rheumatologic diseases patients in the prevention of active tuberculosis diseases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: ESAT6/CFP10 skin testAdult patients with diagnosed rheumatologic diseases scheduled to receive b/tsDMARDs therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatology patients followed up at the Specialist Services of regional hospitals in New Territories East Cluster in Hong Kong (Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and North District Hospital)
Key inclusion criteria (4 listed)
- adult of age ≥ 18 and up to 65 years;
- diagnosis of at least one classified rheumatologic disease; and
- being planned to receive b/tsDMARDs therapy,
- can communicate in Chinese and/or English.
Key exclusion criteria (4 listed)
- diagnosis of active TB diseases,
- currently receiving TB or LTBI treatment;
- concurrent mental illnesses;
- prisoners.
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 |
|---|---|---|
| ESAT6/CFP10 skin testEach recruited participant would be offered standard tuberculin skin test (TST) and ESAT6/CFP10 (C-TST) skin test on the same day or setting of clinical visit. TST and C-TST would be performed by the Mantoux technique with intradermal injection of 2U purified protein derivative-RT23 on one forearm and 5U (1.0µg/0.1 ml) of recombinant fusion protein ESAT6-CFP10 on the other forearm respectively. | Diagnostic test | study group |
Primary outcome
C-TST reading
Time frame: from enrolment to reading test result at 48-72 hours
Concordance between C-TST and standard TST
C-TST reading
Time frame: from enrolment to reading test result at 2 weeks
Concordance between C-TST and IGRA test result
1 secondary outcome
Proportion with TB disease
Time frame: from enrolment to last followup at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No. Access of individual level data at individual level is restricted for protection of privacy, as stipulated in the institutional approval
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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.
David SC Hui, MD study director
Chinese University of Hong Kong
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis (TB), run by Chinese University of Hong Kong at 2 sites in 2 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shui Shan Lee, MD (852 22528812, sslee@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-TST reading (time frame: from enrolment to reading test result at 48-72 hours). 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 10 Sep 2025.