Tuberculosis, PulmonaryTBENOSENCT04682990
DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH (TBENOSE)
A study testing Tor Vergata Electronic Nose (TV eNose), Survey & Physical Exam and TB LAMP test in people with Tuberculosis, Pulmonary and HIV Seropositivity, run by University of Rome Tor Vergata at 1 site in Cameroon.
Trial summary
Tuberculosis (TB) is one of the top 10 causes of death in the world. More than 95% of TB deaths are in middle- and middle-income countries. Low incomes and long-term diagnosis promote this persistence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Pulmonary, HIV Seropositivity
- What is being tested?
- Tor Vergata Electronic Nose (TV eNose), Survey & Physical Exam and TB LAMP test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCameroon
- Study dates
- 5 Jan 2021to 5 Dec 2021
- 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
- Accept to participate in the study through a signed informed consent approved by the Ethical Committee (CEI of Douala - Cameroon)
- Suspected of having TB on clinical base (4SS + or other clinical suggestions) with HIV+/- status
- Healthy control patient
- Able to produce exhaled air samples
- Able to produce sputum samples for TB LAMP test
Who cannot join
- Unable to breath normally for 2 minutes due to respiratory illness
- By discretion of the research team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH TEST Center: Douala - CAMEROON
Tuberculosis (TB) is one of the top 10 causes of death in the world. More than 95% of TB deaths are in middle- and middle-income countries. Low incomes and long-term diagnosis promote this persistence. In 2017, Cameroon was the 3rd in the top of 20 countries with the highest estimated numbers of incident TB cases among people living with HIV, based on the severity of their TB burden.
World Health Organization (WHO) encourages the introduction of rapid, non-invasive and cheaper screening tests. In this scope, this study proposes the collection of exhaled breath samples and their analysis through the electronic nose made in Tor Vergata University (TV eNose) to diagnose TB and TB-HIV on their participants.
Read the detailed description
It is a 12 -month dynamic, open, descriptive and analytical type case-control study in adults. The present study intends to recruit , all the Pulmonary TB suspects and case notified by TB Loop-mediated isothermal Amplification(LAMP), sputum culture or GeneXpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) Assay, Pulmonary TB+HIV patients, healthy control patients, HIV patients without TB. Each patient will undergo at least two tests: the Breath Test Measurement and the TB LAMP. The TB LAMP will be used like the reference test for positive TB cases.
The enrolment phase of the participants will take 12 months. After this period, additional 6 months will be dedicated to the data analysis and dissemination of results.
Each patient meeting the inclusion criteria will be asked to join the study. Detailed information will be provided him/her. In case of acceptance the participants will undergo further sampling: breath test measurement. All data will be collected ensuring anonymity and privacy. Standard protocols used in the center will not be changed by the research, but each patient will be asked to provide 1 additional sample (exhaled breath in the bag sampler). Each study participant will be properly informed, and a consent form will be signed.
Preparation to participate: It will be required to patients to avoid drinking, eating, smoking, or brushing their teeth 2 hours before the breath test.
Sampling collection: In order to collect breath samples, two bags will be used, one for collecting airways breath (about 0.5 liter volume) and one for alveolar exhaled air (3 liters). It is asked to the patient after putting a clip nose, to inspire with the mouth and to deeply breath inside the bags through an antibacterial filter connected to the sampling apparatus.
At the end, the second bag (volume of 3 liters) contains the alveolar portion of breath that will be analyzed by the TV eNose. During the measurement, the TV eNose will be connected to the computer, to read and store the Volatile Organic Compounds (VOCs) pattern from breath given by the sensor array.
Other data are collected: clinical symptoms, TB LAMP results, and results of others test if available: chest X-ray, smear microscopic, sputum culture and GeneXpert MTB/RIF Assay examinations.
All personal data and results of the patients will be collected in a specific sheet elaborated by the partners (University di Roma Tor Vergata). It will be an Excel database and it will be store in the study site. All data collected will be anonymous.
- Conditions
- Tuberculosis, Pulmonary, HIV Seropositivity
- Being tested
- Tor Vergata Electronic Nose (TV eNose), Survey & Physical Exam, TB LAMP test, Sputum Samples, Chest X-Ray
- Keywords
- Tuberculosis, Breath test, Volatile Organic Compounds (VOCs)
- Medical subject headings
- Tuberculosis, Pulmonary, HIV Seropositivity, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tor Vergata Electronic Nose (TV eNose)Device
Participants will be asked to perform a breath sampling with a nose clamp in Alveolar sampling bag. This exhaled breath in the sampling bag will be analyse with the TV eNose
Survey & Physical ExamOther
Perform a oriented survey for risk factors, symptoms and a complete physical exam.
TB LAMP testDiagnostic test
Collection of Sputum samples and Perform TB-LAMP (temperature-independent way of amplifying DNA from TB organisms)
Sputum SamplesOther
Sputum samples for Ziehl Neelsen smear or Culture in L-J (if required by the medical staff)
Chest X-RayOther
Perform anteroposterior chest X-ray (if required by the medical staff)
Follow Up 5 days after beginning of Tx.Other
Following the usual planning of the center for Positive TB Patients, they will be asked to come 5 days after initiation of treatment, to perform another measurement with the device.
Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment.
Follow Up & 15 days after beginning of Tx.Other
Following the usual planning of the center for Positive TB Patients, they will be asked to come during treatment, to perform another measurement with the device.
Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment.
Follow Up & 30 days after beginning of Tx.Other
Following the usual planning of the center for Positive TB Patients, they will be asked to come during treatment, to perform another measurement with the device.
Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary TB | Experimental | This arm will enroll 80-100 patients older than 18 years old, from the Center of Respiratory Diseases in Douala, with pulmonary TB proved by TB LAMP test.
Interventions:
1. They will be asked to perform a breath exhalation with a nose clamp.
2. Medical History: Symptom based Survey, Physical Exam,and HIV status.
Other interventions:
* Sputum samples for Ziehl Neelsen smear or Culture in L-J or GeneXpert MTB/RIF;
* Chest X-ray Follow Up 5 days after beginning of Tx Follow Up 15 days after beginning of Tx Follow Up 30 days after beginning of Tx Receives: Device: Tor Vergata Electronic Nose (TV eNose); Other: Survey & Physical Exam; Diagnostic Test: TB LAMP test; Other: Sputum Samples; Other: Chest X-Ray; Other: Follow Up 5 days after beginning of Tx.; Other: Follow Up & 15 days after beginning of Tx.; Other: Follow Up & 30 days after beginning of Tx. |
| Non Pulmonary TB | Active comparator | This arm will enroll 50-100 patients older than 18 years old, from the Center of Respiratory Diseases in Douala, with Negative pulmonary TB status proved by TB LAMP test. These Negative TB patients can be healthy controls or TB suspects.
Interventions:
They will be asked to perform a breath exhalation with a nose clamp. Medical History: Symptom based Survey, and HIV status.
Other interventions:
* Sputum samples for Ziehl Neelsen smear or Culture in L-J GeneXpert MTB/RIF;
* Chest X-ray. Receives: Device: Tor Vergata Electronic Nose (TV eNose); Other: Survey & Physical Exam; Diagnostic Test: TB LAMP test; Other: Sputum Samples; Other: Chest X-Ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy value of the TV eNose signal value to differentiate patients with Pulmonary TB to control participants
Sensitivity, Specificity and Predictive Values; calculated with an Receiver Operating Characteristic (ROC) curve based on the pattern recognition model from dataset measured by the TV eNose.The classification of the signal is generated with a complex pattern recognition software, using the frequency shift in Hertz (Hz), generated by each of the 12 sensors.
Measured: 6 months
Accuracy value of the diagnostic between Pulmonary TB, Pulmonary TB+ HIV patients and control patients with the TV eNose
Sensitivity, Specificity and Predictive Values; calculated with an Receiver Operating Characteristic (ROC) curve based on the pattern recognition model from dataset measured by the TV eNose. The classification of the signal is generated with a complex pattern recognition software, using the frequency shift in Hertz (Hz), generated by each of the 12 sensors.
Measured: 6 months
Secondary outcomes (1)
Average Days needed to observed a negative result with the device after initiation of treatment.
Get an evolutive model of the VOC pattern of the frequency from each patient under treatment. Characterize VOC pattern of Pulmonary TB with and without treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start5 Jan 2021
- Primary completion5 Dec 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies 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
- Factorial
- Model description
- Positive TB patients (Arm 1) and Negative TB patients (Arm 2 ). All the patients can be HIV positive or not .
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yolande Christelle Ketchanji Mougang, University of Rome Tor Vergata
- Investigators
- Leonardo Palombi, Professor, Study director, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682990
- Sponsor's protocol ID
- TB Project eNose-Cameroon
- Acronym
- TBENOSE
- Status last verified
- Dec 2021
- First submitted
- 4 Dec 2020
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH TEST Center: Douala - CAMEROON
- ClinicalTrials.gov ID
- NCT04682990
- Acronym / sponsor ID
- TBENOSE / TB Project eNose-Cameroon
- Conditions
- Tuberculosis, Pulmonary, HIV Seropositivity
- Keywords
- Tuberculosis, Breath test, Volatile Organic Compounds (VOCs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 24 Dec 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.
Tuberculosis (TB) is one of the top 10 causes of death in the world. More than 95% of TB deaths are in middle- and middle-income countries. Low incomes and long-term diagnosis promote this persistence. In 2017, Cameroon was the 3rd in the top of 20 countries with the highest estimated numbers of incident TB cases among people living with HIV, based on the severity of their TB burden.
World Health Organization (WHO) encourages the introduction of rapid, non-invasive and cheaper screening tests. In this scope, this study proposes the collection of exhaled breath samples and their analysis through the electronic nose made in Tor Vergata University (TV eNose) to diagnose TB and TB-HIV on their participants.
Detailed description
It is a 12 -month dynamic, open, descriptive and analytical type case-control study in adults. The present study intends to recruit , all the Pulmonary TB suspects and case notified by TB Loop-mediated isothermal Amplification(LAMP), sputum culture or GeneXpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) Assay, Pulmonary TB+HIV patients, healthy control patients, HIV patients without TB. Each patient will undergo at least two tests: the Breath Test Measurement and the TB LAMP. The TB LAMP will be used like the reference test for positive TB cases.
The enrolment phase of the participants will take 12 months. After this period, additional 6 months will be dedicated to the data analysis and dissemination of results.
Each patient meeting the inclusion criteria will be asked to join the study. Detailed information will be provided him/her. In case of acceptance the participants will undergo further sampling: breath test measurement. All data will be collected ensuring anonymity and privacy. Standard protocols used in the center will not be changed by the research, but each patient will be asked to provide 1 additional sample (exhaled breath in the bag sampler). Each study participant will be properly informed, and a consent form will be signed.
Preparation to participate: It will be required to patients to avoid drinking, eating, smoking, or brushing their teeth 2 hours before the breath test.
Sampling collection: In order to collect breath samples, two bags will be used, one for collecting airways breath (about 0.5 liter volume) and one for alveolar exhaled air (3 liters). It is asked to the patient after putting a clip nose, to inspire with the mouth and to deeply breath inside the bags through an antibacterial filter connected to the sampling apparatus.
At the end, the second bag (volume of 3 liters) contains the alveolar portion of breath that will be analyzed by the TV eNose. During the measurement, the TV eNose will be connected to the computer, to read and store the Volatile Organic Compounds (VOCs) pattern from breath given by the sensor array.
Other data are collected: clinical symptoms, TB LAMP results, and results of others test if available: chest X-ray, smear microscopic, sputum culture and GeneXpert MTB/RIF Assay examinations.
All personal data and results of the patients will be collected in a specific sheet elaborated by the partners (University di Roma Tor Vergata). It will be an Excel database and it will be store in the study site. All data collected will be anonymous.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Positive TB patients (Arm 1) and Negative TB patients (Arm 2 ). All the patients can be HIV positive or not .
| Arm | Type | Receives |
|---|---|---|
| Pulmonary TB | Experimental | Device: Tor Vergata Electronic Nose (TV eNose), Other: Survey & Physical Exam, Diagnostic Test: TB LAMP test, Other: Sputum Samples, Other: Chest X-Ray, Other: Follow Up 5 days after beginning of Tx., Other: Follow Up & 15 days after beginning of Tx., Other: Follow Up & 30 days after beginning of Tx.This arm will enroll 80-100 patients older than 18 years old, from the Center of Respiratory Diseases in Douala, with pulmonary TB proved by TB LAMP test. Interventions: 1. They will be asked to perform a breath exhalation with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam,and HIV status. Other interventions: * Sputum samples for Ziehl Neelsen smear or Culture in L-J or GeneXpert MTB/RIF; * Chest X-ray Follow Up 5 days after beginning of Tx Follow Up 15 days after beginning of Tx Follow Up 30 days after beginning of Tx |
| Non Pulmonary TB | Active comparator | Device: Tor Vergata Electronic Nose (TV eNose), Other: Survey & Physical Exam, Diagnostic Test: TB LAMP test, Other: Sputum Samples, Other: Chest X-RayThis arm will enroll 50-100 patients older than 18 years old, from the Center of Respiratory Diseases in Douala, with Negative pulmonary TB status proved by TB LAMP test. These Negative TB patients can be healthy controls or TB suspects. Interventions: They will be asked to perform a breath exhalation with a nose clamp. Medical History: Symptom based Survey, and HIV status. Other interventions: * Sputum samples for Ziehl Neelsen smear or Culture in L-J GeneXpert MTB/RIF; * Chest X-ray. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Accept to participate in the study through a signed informed consent approved by the Ethical Committee (CEI of Douala - Cameroon)
- Suspected of having TB on clinical base (4SS + or other clinical suggestions) with HIV+/- status
- Healthy control patient
- Able to produce exhaled air samples
- Able to produce sputum samples for TB LAMP test
Key exclusion criteria (2 listed)
- Unable to breath normally for 2 minutes due to respiratory illness
- By discretion of the research team.
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 |
|---|---|---|
| Tor Vergata Electronic Nose (TV eNose)Participants will be asked to perform a breath sampling with a nose clamp in Alveolar sampling bag. This exhaled breath in the sampling bag will be analyse with the TV eNose | Device | Non Pulmonary TB, Pulmonary TB |
| Survey & Physical ExamPerform a oriented survey for risk factors, symptoms and a complete physical exam. | Other | Non Pulmonary TB, Pulmonary TB |
| TB LAMP testCollection of Sputum samples and Perform TB-LAMP (temperature-independent way of amplifying DNA from TB organisms) | Diagnostic test | Non Pulmonary TB, Pulmonary TB |
| Sputum SamplesSputum samples for Ziehl Neelsen smear or Culture in L-J (if required by the medical staff) | Other | Non Pulmonary TB, Pulmonary TB |
| Chest X-RayPerform anteroposterior chest X-ray (if required by the medical staff) | Other | Non Pulmonary TB, Pulmonary TB |
| Follow Up 5 days after beginning of Tx.Following the usual planning of the center for Positive TB Patients, they will be asked to come 5 days after initiation of treatment, to perform another measurement with the device. Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment. | Other | Pulmonary TB |
| Follow Up & 15 days after beginning of Tx.Following the usual planning of the center for Positive TB Patients, they will be asked to come during treatment, to perform another measurement with the device. Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment. | Other | Pulmonary TB |
| Follow Up & 30 days after beginning of Tx.Following the usual planning of the center for Positive TB Patients, they will be asked to come during treatment, to perform another measurement with the device. Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment. | Other | Pulmonary TB |
Primary outcome
Diagnostic Accuracy value of the TV eNose signal value to differentiate patients with Pulmonary TB to control participants
Time frame: 6 months
Sensitivity, Specificity and Predictive Values; calculated with an Receiver Operating Characteristic (ROC) curve based on the pattern recognition model from dataset measured by the TV eNose.The classification of the signal is generated with a complex pattern recognition software, using the frequency shift in Hertz (Hz), generated by each of the 12 sensors.
Accuracy value of the diagnostic between Pulmonary TB, Pulmonary TB+ HIV patients and control patients with the TV eNose
Time frame: 6 months
Sensitivity, Specificity and Predictive Values; calculated with an Receiver Operating Characteristic (ROC) curve based on the pattern recognition model from dataset measured by the TV eNose. The classification of the signal is generated with a complex pattern recognition software, using the frequency shift in Hertz (Hz), generated by each of the 12 sensors.
1 secondary outcome
Average Days needed to observed a negative result with the device after initiation of treatment.
Time frame: 6 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 8 Dec 2021.
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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.
Leonardo Palombi, Professor study director
University of Rome Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tor Vergata Electronic Nose (TV eNose), Survey & Physical Exam and TB LAMP test in people with Tuberculosis, Pulmonary and HIV Seropositivity, run by University of Rome Tor Vergata at 1 site in Cameroon.
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 5 inclusion and 2 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 8 Dec 2021. 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 Cameroon. 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 Accuracy value of the TV eNose signal value to differentiate patients with Pulmonary TB to control participants (time frame: 6 months). 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 8 Dec 2021.