Volatile Organic CompoundsPrinoseNCT04407325
Tuberculosis Screening in Paraguayan Prisons
A study testing electronic nose device and dig chest Xray with automated readings in people with Volatile Organic Compounds and Radiography, run by Radboud University Medical Center at 2 sites in Paraguay.
Trial summary
Two diagnostic tools for TB screening in high risk groups need additional assessment: the AeoNose™, an 'electronic nose device' for breath sampling, and digital chest X-ray (CXR) with computer aided detection with CAD4TB® software. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volatile Organic Compounds, Radiography
- What is being tested?
- electronic nose device and dig chest Xray with automated readings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 2 sitesParaguay
- Study dates
- 18 Oct 2021to 1 Dec 2023
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All persons, either being a prisoner or employee, of the involved penal institutions after providing informed consent, including those with known active TB disease and/or currently on TB treatment
Who cannot join
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- Unable to exhale breath through the AeoNose™ during five minutes due to respiratory insufficiency
- Unable to stand in an upright position for the CXR
- Unable to communicate and comply with the instructions of the study team
Trial locations and contacts
2 sites in 1 country.
Paraguay2 sites, 1 recruiting
- Recruiting
Buen Pastor
Asuncion, Central Department
Claudia Pinanez, MD, claupinanez@hotmail.com
- Completed
UPI
Asuncion, Central Department
About this study
Official title: Tuberculosis Screening With AeoNose and CAD4TB in Paraguayan Prisons
Two diagnostic tools for TB screening in high risk groups need additional assessment: the AeoNose™, an 'electronic nose device' for breath sampling, and digital chest X-ray (CXR) with computer aided detection with CAD4TB® software. This study will systematically screen prisoners and its' employees for TB, test the diagnostic performance of AeoNose™ and CAD4TB (both individually and together) as a TB screening tool and and establish Mycobacterium tuberculosis epidemiology in Paraguayan prisons.
Read the detailed description
The aim of the World Health Organization (WHO) "End TB Strategy" is to end the global pandemic by 2035. To be able to succeed, better point-of-care (POC) tests are urgently needed to improve screening of high-risk populations. Prisons are recognized worldwide as high risk environments for the concentration, amplification and transmission of TB among prisoners and their communities outside. Paraguayan penal institutions are known to have very high incidence rates of active TB (3000-5000/100.000, according to Paraguayan Ministry of Justice). Two diagnostic tools for TB screening in high risk groups will be evaluated: the AeoNose™, an 'electronic nose device' for breath sampling, and digital chest X-ray (CXR) with computer aided detection with CAD4TB® software. This study will systematically screen prisoners and its' employees for TB, test the diagnostic performance of AeoNose™ and CAD4TB® and assess prison Mycobacterium tuberculosis epidemiology through several objectives: Objective: 1. Assessment of the sensitivity and specificity of the AeoNose™ and its utility for mass TB screening in high incidence settings. 2. Evaluation of the feasibility and utility of CAD4TB® digital CXR as a mass screening tool for TB. 3. Identification of factors that affect diagnostic accuracy of AeoNose™ and CAD4TB®. 4. Assessment of TB epidemiology in Paraguayan prisons and identification of mycobacterial strains.
Study design: Diagnostic cohort study. Study population: Detainees (PPL) of Paraguayan penal institutions as well as their employees. Nature and extent of the burden and risks associated with participation, benefit and group relatedness.
Individual burden: all participants will perform one visit with a medical doctor for medical history, physical exam, digital X-ray (with CAD4TB®) and AeoNose sampling. Participants will be offered voluntary HIV testing and counseling. In case of presumptive TB (estimated 20-30% of participants) two sputum samples will be taken, either spontaneous or saline-induced. One sample is tested with GeneXpert and the other with liquid mycobacterial culture. Cases of presumptive TB with both negative GeneXpert® and culture results will be followed-up after three and six months for repeat testing.
- Conditions
- Volatile Organic Compounds, Radiography
- Being tested
- electronic nose device, dig chest Xray with automated readings
- Keywords
- tuberculosis, vulnerable populations, screening algorithms, cost effectiveness, neural networks, artificial intelligence
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic nose deviceDevice
Also called (AeoNose, The eNose Company, the Netherlands)
electronic nose device will be tested as a triage instrument for tuberculosis in a high risk population
dig chest Xray with automated readingsDevice
Also called CAD4TB computed automated detection software
software for tuberculosis detection on digital Chest Xray providing a probability score from 0-100
| Study group | Role | What they receive |
|---|---|---|
| AeoNose | Experimental | the AeoNose will be compared with digital ChestXray and the conventional methods of establishing TB diagnosis Receives: Device: electronic nose device; Device: dig chest Xray with automated readings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volatile organic compound signal as measured with the AeoNose™
The exhaled breath 'smell print' of each participant will be compared over time at baseline, 3 months and 6 months with sputum microbiology results and digital Chest Xray to establish sensitivity and specificity of electronic nose signal to diagnose Tuberculosis
Measured: Baseline/ change from baseline at 3 and 6 months
Tuberculosis probablity score using Computed Automated detection software CAD4TB® on chest Xrays
Ranges from 0 to 100, where 0 would mean the lowest probability of having Tuberculosis and 100 would be the highest probability of having Tuberculosis.
Measured: Baseline/ change from baseline at 3 and 6 months
Positive mycobacterial sputum test
positive GenXpert test and/or mycobacterial cultures are used to establish Tuberculosis diagnosis
Measured: Baseline/ change from baseline at 3 and 6 months
Secondary outcomes (2)
Comparison of predictive value of volatile organic compound signal with Tuberculosis Probability Score
comparison of correct positive predictions for active TB, with AeoNose (positive/ negative test result) and Cad4TB software from chest Xrays providing probability scores from 0-100 points
Measured: Baseline/ change from baseline at 3 and 6 months
added value of the use of AeoNose and Cad4TB as a TB screening algorithm in vulnerable populations
evaluation of the combined use of both AeoNose and Cad4TB probability score to predict active TB
Measured: Baseline/ change from baseline at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start18 Oct 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volatile Organic CompoundsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- outcomes of individual smell prints and digital ChestXrays will be compared with sputum sampling for GenXpert and Mycobacterial culture
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, Instituto de Saude Publica da Universidade do Porto, VHIR, University Medical Center Groningen, Laboratorio central de salud publica, Paraguay, Instituto Nacional de Enfermedades Respiratorias y del Ambiente Juan Max Boetner, National TB program Paraguay, IICS Paraguay
- Responsible party
- Sponsor
- Investigators
- Cecile Magis-Escurra, MD,PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407325
- Sponsor's protocol ID
- 823890-EUSAT-RCS
- Acronym
- Prinose
- Status last verified
- Mar 2023
- First submitted
- 23 Apr 2020
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuberculosis Screening With AeoNose and CAD4TB in Paraguayan Prisons
- ClinicalTrials.gov ID
- NCT04407325
- Acronym / sponsor ID
- Prinose / 823890-EUSAT-RCS
- Conditions
- Volatile Organic Compounds, Radiography
- Keywords
- tuberculosis, vulnerable populations, screening algorithms, cost effectiveness, neural networks, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- European Union, Instituto de Saude Publica da Universidade do Porto, VHIR, University Medical Center Groningen, Laboratorio central de salud publica, Paraguay, Instituto Nacional de Enfermedades Respiratorias y del Ambiente Juan Max Boetner, National TB program Paraguay, IICS Paraguay
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 29 May 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.
Two diagnostic tools for TB screening in high risk groups need additional assessment: the AeoNose™, an 'electronic nose device' for breath sampling, and digital chest X-ray (CXR) with computer aided detection with CAD4TB® software. This study will systematically screen prisoners and its' employees for TB, test the diagnostic performance of AeoNose™ and CAD4TB (both individually and together) as a TB screening tool and and establish Mycobacterium tuberculosis epidemiology in Paraguayan prisons.
Detailed description
The aim of the World Health Organization (WHO) "End TB Strategy" is to end the global pandemic by 2035. To be able to succeed, better point-of-care (POC) tests are urgently needed to improve screening of high-risk populations. Prisons are recognized worldwide as high risk environments for the concentration, amplification and transmission of TB among prisoners and their communities outside. Paraguayan penal institutions are known to have very high incidence rates of active TB (3000-5000/100.000, according to Paraguayan Ministry of Justice). Two diagnostic tools for TB screening in high risk groups will be evaluated: the AeoNose™, an 'electronic nose device' for breath sampling, and digital chest X-ray (CXR) with computer aided detection with CAD4TB® software. This study will systematically screen prisoners and its' employees for TB, test the diagnostic performance of AeoNose™ and CAD4TB® and assess prison Mycobacterium tuberculosis epidemiology through several objectives: Objective: 1. Assessment of the sensitivity and specificity of the AeoNose™ and its utility for mass TB screening in high incidence settings. 2. Evaluation of the feasibility and utility of CAD4TB® digital CXR as a mass screening tool for TB. 3. Identification of factors that affect diagnostic accuracy of AeoNose™ and CAD4TB®. 4. Assessment of TB epidemiology in Paraguayan prisons and identification of mycobacterial strains.
Study design: Diagnostic cohort study. Study population: Detainees (PPL) of Paraguayan penal institutions as well as their employees. Nature and extent of the burden and risks associated with participation, benefit and group relatedness.
Individual burden: all participants will perform one visit with a medical doctor for medical history, physical exam, digital X-ray (with CAD4TB®) and AeoNose sampling. Participants will be offered voluntary HIV testing and counseling. In case of presumptive TB (estimated 20-30% of participants) two sputum samples will be taken, either spontaneous or saline-induced. One sample is tested with GeneXpert and the other with liquid mycobacterial culture. Cases of presumptive TB with both negative GeneXpert® and culture results will be followed-up after three and six months for repeat testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- outcomes of individual smell prints and digital ChestXrays will be compared with sputum sampling for GenXpert and Mycobacterial culture
| Arm | Type | Receives |
|---|---|---|
| AeoNose | Experimental | Device: electronic nose device, Device: dig chest Xray with automated readingsthe AeoNose will be compared with digital ChestXray and the conventional methods of establishing TB diagnosis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All persons, either being a prisoner or employee, of the involved penal institutions after providing informed consent, including those with known active TB disease and/or currently on TB treatment
Key exclusion criteria (4 listed)
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
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 |
|---|---|---|
| electronic nose deviceAlso: (AeoNose, The eNose Company, the Netherlands)electronic nose device will be tested as a triage instrument for tuberculosis in a high risk population | Device | AeoNose |
| dig chest Xray with automated readingsAlso: CAD4TB computed automated detection softwaresoftware for tuberculosis detection on digital Chest Xray providing a probability score from 0-100 | Device | AeoNose |
Primary outcome
Volatile organic compound signal as measured with the AeoNose™
Time frame: Baseline/ change from baseline at 3 and 6 months
The exhaled breath 'smell print' of each participant will be compared over time at baseline, 3 months and 6 months with sputum microbiology results and digital Chest Xray to establish sensitivity and specificity of electronic nose signal to diagnose Tuberculosis
Tuberculosis probablity score using Computed Automated detection software CAD4TB® on chest Xrays
Time frame: Baseline/ change from baseline at 3 and 6 months
Ranges from 0 to 100, where 0 would mean the lowest probability of having Tuberculosis and 100 would be the highest probability of having Tuberculosis.
Positive mycobacterial sputum test
Time frame: Baseline/ change from baseline at 3 and 6 months
positive GenXpert test and/or mycobacterial cultures are used to establish Tuberculosis diagnosis
2 secondary outcomes
Comparison of predictive value of volatile organic compound signal with Tuberculosis Probability Score
Time frame: Baseline/ change from baseline at 3 and 6 months
added value of the use of AeoNose and Cad4TB as a TB screening algorithm in vulnerable populations
Time frame: Baseline/ change from baseline at 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- EUSAT-RCS TB research consortiumLink provided by the sponsor.
- 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.
Cecile Magis-Escurra, MD,PhD principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic nose device and dig chest Xray with automated readings in people with Volatile Organic Compounds and Radiography, run by Radboud University Medical Center at 2 sites in Paraguay.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Apr 2023. 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 Paraguay. 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 Luis Gomez Pacielo, MD (+595961889657, luis.gomez@RadboudUMC.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volatile organic compound signal as measured with the AeoNose™ (time frame: Baseline/ change from baseline at 3 and 6 months). The study lists 3 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 3 Apr 2023.