Pulmonary Tuberculosis SuspectedYOGYATBNOSENCT02219945
ENOSE in Pulmonary Tuberculosis in Yogyakarta
A study testing 5 min exhaled breath sampling with soft nose clamp in people with Pulmonary Tuberculosis Suspected and Other Specified Chronic Obstructive Pulmonary Disease, run by Tjip van der Werf at 1 site in Indonesia.
Trial summary
Electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Tuberculosis Suspected, Other Specified Chronic Obstructive Pulmonary Disease, Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology
- What is being tested?
- 5 min exhaled breath sampling with soft nose clamp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2013to Apr 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >18yrs
- voluntarily participating
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
patients - at 5 lung clinics (Minggiran, Kalasan, Kotagede, Bantul, Kuonprogo) connected with Sudjarto Teachnig Hospital; healthy controls among students and staff of Hospital and Gadjah Mada Universitas
Yogyakarta, Jalan Kesehatan No.1, Yogyakarta, 55281
About this study
Official title: The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients
Electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%. Here the investigators test a production type point-of-care hand-held device with less detectors. The investigators explore factors such as food intake, smoking, and co-morbidity, as well as the impact of TB treatment, and address the question whether the device could help monitor disease and response to treatment.
Read the detailed description
Study participants provide WIC and after time for consideration, when they approve, provide demographic anonymized data.
The study population consists of six groups:
Group 1 - 20 TB patients aged > 18 yrs Group 2 - 20 non---TB patients > 18 yrs (screened for TB - other conditions) Group 3 - 20 patients with a lung disease - no TB suspects (Lung Clinics in Yogyakarta,Indonesia; Group 4 - 50 apparently healthy matched controls Group 5 - 20 newly diagnosed TB patients enrolled before start of treatment, to be followed over time, until after end of treatment (8 months FU).
Group 6 - 50 apparently healthy volunteers.
Study participants breath normally by mouthpiece into the device using a nose clamp - for 5 min during each sampling.
Electronic data are downloaded and transmitted by internet to Zutphen, Netherlands where data are processed to build the model.
- Conditions
- Pulmonary Tuberculosis Suspected, Other Specified Chronic Obstructive Pulmonary Disease, Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology
- Being tested
- 5 min exhaled breath sampling with soft nose clamp
- Keywords
- pulmonary tuberculosis; electronic nose; diagnostic accuracy
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 min exhaled breath sampling with soft nose clampOther
Also called AEONOSE portable exhaled breath sampling
study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - 20 PTB patients aged >18yrs | Experimental | Group 1 - 20 TB patients aged > 18 yrs 5 min exhaled breath sampling with nose clamp Receives: Other: 5 min exhaled breath sampling with soft nose clamp |
| Group 2 - 20 TB suspects > 18 yrs | Experimental | Group 2 - 20 non-TB patients > 18 yrs (screened for TB - but appear to test negative for TB, and diagnosed with other conditions including bronchiectasis, etc) 5 min exhaled breath sampling with nose clamp Receives: Other: 5 min exhaled breath sampling with soft nose clamp |
| group 3 - 20 lung patients, non-TB | Experimental | Group 3 - 20 patients with a lung disease - no TB suspects (recruited from Lung Clinics in Yogyakarta; lung cancer, COPD, etc) 5 min exhaled breath sampling with nose clamp Receives: Other: 5 min exhaled breath sampling with soft nose clamp |
| Group 4 - 20 healthy controls | Experimental | Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp Receives: Other: 5 min exhaled breath sampling with soft nose clamp |
| Group 5 - 7 newly diagnosedMDR PTB pts | Experimental | Group 5 - 7 newly diagnosed MDRTB patients enrolled before start of treatment, to be followed 8 months, until after end of treatment 5 min exhaled breath sampling with nose clamp Receives: Other: 5 min exhaled breath sampling with soft nose clamp |
| group 6 - cohort of TB suspects | Experimental | 300 more individuals, suspected to have TB - final diagnosis by standard procedures plus sputum culture plus follow-up for >2 years 5 min exhaled breath sampling with nose clamp Receives: Other: 5 min exhaled breath sampling with soft nose clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic precision of electronic nose signal in pulmonary TB
sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB
Measured: 18 months
Secondary outcomes (1)
measuring response to TB treatment over time with the electronic nose
cohort of patients newly deteted with PTB will be followed with the enose device over time to monitor disease activity, until end of treatment
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 posted19 Aug 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionApr 2017
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 Pulmonary Tuberculosis SuspectedStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 6 groups: 1\) 20 TB patients 2) 20 non-TB patients (alternative diagnosis) 3) 20 patients with chest symptoms - non-TB 4) 7 MDR-TB patients 5) 20 healthy controls 6) 300 subjects suspected to have pulmonary tuberculosis - follow-up for 2.5 years
- Masking
- None (open label)
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tjip van der Werf
- Sponsor type
- University, hospital or other
- Collaborators
- Gadjah Mada University, The eNose Company
- Responsible party
- Sponsor-investigator, Tjip van der Werf, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219945
- Sponsor's protocol ID
- TBDIAGNOSE
- Other IDs
- KE/FK/859/EC
- Acronym
- YOGYATBNOSE
- Status last verified
- May 2017
- First submitted
- 1 Aug 2014
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Saktiawati AMI, Subronto YW, Stienstra Y, Sumardi, Supit F, van der Werf TS. Sensitivity and specificity of routine diagnostic work-up for tuberculosis in lung clinics in Yogyakarta, Indonesia: a cohort study. BMC Public Health. 2019 Apr 2;19(1):363. doi: 10.1186/s12889-019-6658-8.
PubMed 30940123
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients
- ClinicalTrials.gov ID
- NCT02219945
- Acronym / sponsor ID
- YOGYATBNOSE / TBDIAGNOSE
- Conditions
- Pulmonary Tuberculosis Suspected, Other Specified Chronic Obstructive Pulmonary Disease, Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology
- Keywords
- pulmonary tuberculosis; electronic nose; diagnostic accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Tjip van der WerfUniversity, hospital or other
- Collaborators
- Gadjah Mada University, The eNose Company
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 19 Aug 2014 (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.
Electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%. Here the investigators test a production type point-of-care hand-held device with less detectors. The investigators explore factors such as food intake, smoking, and co-morbidity, as well as the impact of TB treatment, and address the question whether the device could help monitor disease and response to treatment.
Detailed description
Study participants provide WIC and after time for consideration, when they approve, provide demographic anonymized data.
The study population consists of six groups:
Group 1 - 20 TB patients aged > 18 yrs Group 2 - 20 non---TB patients > 18 yrs (screened for TB - other conditions) Group 3 - 20 patients with a lung disease - no TB suspects (Lung Clinics in Yogyakarta,Indonesia; Group 4 - 50 apparently healthy matched controls Group 5 - 20 newly diagnosed TB patients enrolled before start of treatment, to be followed over time, until after end of treatment (8 months FU).
Group 6 - 50 apparently healthy volunteers.
Study participants breath normally by mouthpiece into the device using a nose clamp - for 5 min during each sampling.
Electronic data are downloaded and transmitted by internet to Zutphen, Netherlands where data are processed to build the model.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 6 groups: 1) 20 TB patients 2) 20 non-TB patients (alternative diagnosis) 3) 20 patients with chest symptoms - non-TB 4) 7 MDR-TB patients 5) 20 healthy controls 6) 300 subjects suspected to have pulmonary tuberculosis - follow-up for 2.5 years
| Arm | Type | Receives |
|---|---|---|
| Group 1 - 20 PTB patients aged >18yrs | Experimental | Other: 5 min exhaled breath sampling with soft nose clampGroup 1 - 20 TB patients aged > 18 yrs 5 min exhaled breath sampling with nose clamp |
| Group 2 - 20 TB suspects > 18 yrs | Experimental | Other: 5 min exhaled breath sampling with soft nose clampGroup 2 - 20 non-TB patients > 18 yrs (screened for TB - but appear to test negative for TB, and diagnosed with other conditions including bronchiectasis, etc) 5 min exhaled breath sampling with nose clamp |
| group 3 - 20 lung patients, non-TB | Experimental | Other: 5 min exhaled breath sampling with soft nose clampGroup 3 - 20 patients with a lung disease - no TB suspects (recruited from Lung Clinics in Yogyakarta; lung cancer, COPD, etc) 5 min exhaled breath sampling with nose clamp |
| Group 4 - 20 healthy controls | Experimental | Other: 5 min exhaled breath sampling with soft nose clampGroup 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp |
| Group 5 - 7 newly diagnosedMDR PTB pts | Experimental | Other: 5 min exhaled breath sampling with soft nose clampGroup 5 - 7 newly diagnosed MDRTB patients enrolled before start of treatment, to be followed 8 months, until after end of treatment 5 min exhaled breath sampling with nose clamp |
| group 6 - cohort of TB suspects | Experimental | Other: 5 min exhaled breath sampling with soft nose clamp300 more individuals, suspected to have TB - final diagnosis by standard procedures plus sputum culture plus follow-up for >2 years 5 min exhaled breath sampling with nose clamp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age >18yrs
- voluntarily participating
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| 5 min exhaled breath sampling with soft nose clampAlso: AEONOSE portable exhaled breath samplingstudy participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc | Other | Group 1 - 20 PTB patients aged >18yrs, Group 2 - 20 TB suspects > 18 yrs, Group 4 - 20 healthy controls, Group 5 - 7 newly diagnosedMDR PTB pts, group 3 - 20 lung patients, non-TB, group 6 - cohort of TB suspects |
Primary outcome
diagnostic precision of electronic nose signal in pulmonary TB
Time frame: 18 months
sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB
1 secondary outcome
measuring response to TB treatment over time with the electronic nose
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 1 Jun 2017.
- Derived from this study: PubMed 30940123Saktiawati AMI, Subronto YW, Stienstra Y, Sumardi, Supit F, van der Werf TS. Sensitivity and specificity of routine diagnostic work-up for tuberculosis in lung clinics in Yogyakarta, Indonesia: a cohort study. BMC Public Health. 2019 Apr 2;19(1):363. doi: 10.1186/s12889-019-6658-8.
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?
A study testing 5 min exhaled breath sampling with soft nose clamp in people with Pulmonary Tuberculosis Suspected and Other Specified Chronic Obstructive Pulmonary Disease, run by Tjip van der Werf at 1 site in Indonesia.
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 1 Jun 2017. 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 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?
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 precision of electronic nose signal in pulmonary TB (time frame: 18 months). 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 NCT02219945, 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 1 Jun 2017.