TuberculosisNCT04567498
eNose-TB: Electronic Nose for Tuberculosis Screening
A study testing exhaled breath sampling in people with Tuberculosis, run by Gadjah Mada University at 3 sites in Indonesia.
Trial summary
An electronic-nose (e-nose) is being investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- exhaled breath sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,778 participants
- Where
- 3 sitesIndonesia
- Study dates
- 2 Dec 2021to 31 Dec 2024
- Phase
- Interventional
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
- Inclusion Criteria:
Validation Phase (Group 1):
- Adult and children
- Suspected of having TB
- Agree to participate in the study
- Able to produce exhaled air samples
- Able to produce samples for Xpert MTB/Rif examination
Screening Phase (Group 2):
- Adult and children
- Agree to participate in the study
- Able to produce exhaled air samples
- Currently not in TB treatment
- Exclusion Criteria
- Invalid measurements of breath tests
- Incomplete CXR data
- Missing specimens
- Unable to breath normally for 2 minutes due to respiratory illness
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Balai Kesehatan Masyarakat Klaten
Klaten, Central Java, 50131
Primary health centers and hospital
Timika, Special Region of Papua
Primary health centers and hospital
Yogyakarta, Special Region of Yogyakarta
About this study
Official title: eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia
An electronic-nose (e-nose) is being investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Here the investigators test the device in order to analyze the sensitivity and specificity electronic-nose as a screening tool for tuberculosis particularly in remote area. Various factors (gender, age, race, and location) are considered in the algorithm training to develop an inclusive eNose. Access barriers, especially those faced by women, are also assessed.
Read the detailed description
The study population consists of 2 groups:
Group 1 - presumptive TB patients. Group 2 - residents of area with high risk of TB.
Study participants provide written informed consent. The participants are asked to breathe normally using a mask for 2 times then inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full (two times). The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter protecting the e-nose from microbes. The breath pattern will be recorded in the e-nose device, which is connected to a laptop that will display the recorded breath pattern. Other data are collected: clinical symptoms, results of chest X-ray, smear microscopic, and Xpert MTB/Rif examinations.
Demographic (gender, age, race, and location) and clinical data (symptoms, physical examination, laboratory examinations) are collected. Access barriers, especially for women, are also assessed through questionnaire and interviews.
- Conditions
- Tuberculosis
- Being tested
- exhaled breath sampling
- Keywords
- electronic-nose, breath test, tuberculosis, screening, gender, remote area
- Medical subject headings
- Tuberculosis, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exhaled breath samplingOther
The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine.
| Study group | Role | What they receive |
|---|---|---|
| Presumptive TB patients and residents of area with high risk of TB | Experimental | Presumptive TB patients consists of 395 participants - adult and children, while Residents of area with high risk of TB consists of 1383 participants - adult and children) Receives: Other: exhaled breath sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of electronic nose signal in screening tuberculosis that is measured through sensitivity, specificity, PPV, NPV
sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB, factors influencing the diagnostic accuracy
Measured: 2 years
Access barriers, measured through questionnaire, interview, and focus group discussion
access barriers to the TB screening that are measured through questionnaire, interview, and focus group discussion
Measured: 2 years
Secondary outcomes (1)
Time of a screening algorithm with eNose-TB, measured in days
Time of a screening algorithm with eNose-TB to obtain additional detection of one TB case, measured in days
Measured: 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 Sep 2020
- Study start2 Dec 2021
- Primary completion28 Feb 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The Validation phase involves presumptive TB patients (Group 1) and the Screening phase involves residents of area with high risk of TB (Group 2)
- Masking
- None (open label)
- Enrolment
- 1,778 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Morita Iswari Saktiawati, Gadjah Mada University
- Investigators
- Antonia Saktiawati, MD, PhD, Principal investigator, Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567498
- Sponsor's protocol ID
- 002/2019
- Status last verified
- Jul 2024
- First submitted
- 10 Sep 2020
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saktiawati AMI, Triyana K, Wahyuningtias SD, Dwihardiani B, Julian T, Hidayat SN, Ahmad RA, Probandari A, Mahendradhata Y. eNose-TB: A trial study protocol of electronic nose for tuberculosis screening in Indonesia. PLoS One. 2021 Apr 21;16(4):e0249689. doi: 10.1371/journal.pone.0249689. eCollection 2021.
PubMed 33882070
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia
- ClinicalTrials.gov ID
- NCT04567498
- Acronym / sponsor ID
- 002/2019
- Conditions
- Tuberculosis
- Keywords
- electronic-nose, breath test, tuberculosis, screening, gender, remote area
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,778 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Sep 2020 (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.
An electronic-nose (e-nose) is being investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Here the investigators test the device in order to analyze the sensitivity and specificity electronic-nose as a screening tool for tuberculosis particularly in remote area. Various factors (gender, age, race, and location) are considered in the algorithm training to develop an inclusive eNose. Access barriers, especially those faced by women, are also assessed.
Detailed description
The study population consists of 2 groups:
Group 1 - presumptive TB patients. Group 2 - residents of area with high risk of TB.
Study participants provide written informed consent. The participants are asked to breathe normally using a mask for 2 times then inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full (two times). The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter protecting the e-nose from microbes. The breath pattern will be recorded in the e-nose device, which is connected to a laptop that will display the recorded breath pattern. Other data are collected: clinical symptoms, results of chest X-ray, smear microscopic, and Xpert MTB/Rif examinations.
Demographic (gender, age, race, and location) and clinical data (symptoms, physical examination, laboratory examinations) are collected. Access barriers, especially for women, are also assessed through questionnaire and interviews.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Validation phase involves presumptive TB patients (Group 1) and the Screening phase involves residents of area with high risk of TB (Group 2)
| Arm | Type | Receives |
|---|---|---|
| Presumptive TB patients and residents of area with high risk of TB | Experimental | Other: exhaled breath samplingPresumptive TB patients consists of 395 participants - adult and children, while Residents of area with high risk of TB consists of 1383 participants - adult and children) |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| exhaled breath samplingThe participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine. | Other | Presumptive TB patients and residents of area with high risk of TB |
Primary outcome
Diagnostic accuracy of electronic nose signal in screening tuberculosis that is measured through sensitivity, specificity, PPV, NPV
Time frame: 2 years
sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB, factors influencing the diagnostic accuracy
Access barriers, measured through questionnaire, interview, and focus group discussion
Time frame: 2 years
access barriers to the TB screening that are measured through questionnaire, interview, and focus group discussion
1 secondary outcome
Time of a screening algorithm with eNose-TB, measured in days
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 33882070Saktiawati AMI, Triyana K, Wahyuningtias SD, Dwihardiani B, Julian T, Hidayat SN, Ahmad RA, Probandari A, Mahendradhata Y. eNose-TB: A trial study protocol of electronic nose for tuberculosis screening in Indonesia. PLoS One. 2021 Apr 21;16(4):e0249689. doi: 10.1371/journal.pone.0249689. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Antonia Saktiawati, MD, PhD principal investigator
Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exhaled breath sampling in people with Tuberculosis, run by Gadjah Mada University at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. 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?
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 accuracy of electronic nose signal in screening tuberculosis that is measured through sensitivity, specificity, PPV, NPV (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT04567498, which also lists 1 linked publication.
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 19 Jul 2024.