Invasive AspergillosisUHNNCT06344117
Assessment of Volatile Organic Compounds (VOC) for the Diagnosis of Invasive Aspergillosis (IA) in Lung Transplant Recipients
An observational study of Invasive Aspergillosis, run by Owlstone Ltd at 1 site in Canada.
Trial summary
Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease (IFD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Aspergillosis
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2023to Dec 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Lung transplant recipient patients undergoing bronchoscopy as a standard of care for suspected invasive fungal disease (IFD) or surveillance appointments will be eligible for screening.
Inclusion Criteria: Patients with the following criteria will be included in the study:
- Over the age of 18 years
- Recipient of single/double lung transplant
- Willingness to participate in the study
- Suspected of invasive fungal disease or undergo surveillance appointments
- Capable of providing sample
- Capable of providing consent -
Exclusion Criteria: Patients with the following criteria will be excluded from the study:
- On mechanical ventilation, oxygen supplementation including nasal cannula; simple, fixed, or non-rebreathing face mask at presentation.
- Admitted to the intensive care unit at presentation.
- The subject is currently diagnosed with a confirmed bacterial or viral respiratory infection or has received a diagnosis of a respiratory viral or bacterial infection within the last 4 weeks.
- Previous diagnosis of Cystic Fibrosis
- Use of antifungals in previous 4 weeks
- Has been previously diagnosed with respiratory fungal infection other than aspergillus within the last 3 months upon presentation.
- Declines participation in the study.
- On mold antifungal for >72 hours. -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2N2
Shahid Husain, MD,MS, (416) 340-3144, shahid.husain@uhn.ca
Shahid Husain, MD,MS
About this study
Official title: Assessment of Volatile Organic Compounds (VOC) for the Diagnosis of Invasive Aspergillosis (IA) in Lung Transplant Recipients A Prospective Pilot Study
Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease (IFD).
Read the detailed description
Invasive aspergillosis (IA) remains a major cause of morbidity and mortality in immunosuppressed patients. The diagnosis of IA is challenging due to lack of sensitive and specific clinical and radiological signs, and tissue biopsy is often precluded in many patients. Culture and microscopy of respiratory tract samples are relatively insensitive diagnostic tests. Early detection of IA can lead to specific therapeutic strategies and improved patient outcomes. Breath is a rich and complex sampling medium containing both volatile organic compounds (VOCs) and respiratory droplets carrying non-volatiles, proteins, lipids, viruses and even bacteria. The major advantage of exhaled breath analysis is non-invasiveness, with existing sampling methods already readily available.
The diagnostic or prognostic value of exhaled breath analysis has been evaluated in many respiratory diseases, including asthma, Chronic Obstructive Pulmonary Disease, idiopathic pulmonary fibrosis, as well as in some lung infections such as bacterial pneumonia. In the particular field of aspergillosis diagnosis, using a chromatographic-mass spectrometry analysis of exhaled breath in immunocompromised hosts (organ transplantation, hematological malignancies or HSCT), researchers have been able to identify an exhaled breath metabolic signature (made of β-trans-bergamotene, α-trans-bergamotene, a β-vatirenene-like sesquiterpene, and trans-geranylacetone) that potentially allows the discrimination of probable or proven aspergillosis from other lung infections, with high levels of sensitivity and specificity. Exhaled breath therefore appears as a promising field for the improvement of IA diagnosis, and more broadly of respiratory infections. Volatile organic compound (VOC) detection via thermal desorption/gas chromatography-mass spectrometry has emerged as a promising tool for early diagnosis of IA, however the sample sizes have been limited. As such, the proposed pilot study aims to identify potential VOC biomarkers for both IA and Aspergillus colonization and assess the feasibility of VOCs on breath for the diagnosis of IA in lung transplant recipients.
- Conditions
- Invasive Aspergillosis
- Keywords
- Invasive Aspergillosis, VOC, Breath, Lung Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controls | patients without evidence of Aspergillus colonization or Aspergillus related disease | |
| Colonised Aspergillus | patients with Aspergillus colonization | |
| Invasive Aspergillus | patients with proven or probably IA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying a statistical relationship between Volatile Organic Compounds detection and the diagnosis of IA by existing International Society for Heart and Lung Transplantation (ISHLT) and MSG/EORTC criteria.
Identifying a statistical relationship between Volatile Organic Compounds detection and the diagnosis of IA by existing International Society for Heart and Lung Transplantation (ISHLT) and European Organization for Research and Treatment of Cancer/Mycoses Study Group (MSG/EORTC) criteria.
Measured: 18 months
Secondary outcomes (1)
Identifying a statistical relationship between the set of VOCs found in exhaled breath and the diagnosis of Aspergillus colonization as defined by ISHLT criteria
Identifying a statistical relationship between the set of VOCs found in exhaled breath and the diagnosis of Aspergillus colonization as defined by ISHLT criteria
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 posted3 Apr 2024
- Study start12 Dec 2023
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive AspergillosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Owlstone Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shahid Husain, MD,MS, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344117
- Sponsor's protocol ID
- MF3 UHN (IA)
- Acronym
- UHN
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Volatile Organic Compounds (VOC) for the Diagnosis of Invasive Aspergillosis (IA) in Lung Transplant Recipients A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT06344117
- Acronym / sponsor ID
- UHN / MF3 UHN (IA)
- Conditions
- Invasive Aspergillosis
- Keywords
- Invasive Aspergillosis, VOC, Breath, Lung Transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Owlstone LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Apr 2024 (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.
Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease (IFD).
Detailed description
Invasive aspergillosis (IA) remains a major cause of morbidity and mortality in immunosuppressed patients. The diagnosis of IA is challenging due to lack of sensitive and specific clinical and radiological signs, and tissue biopsy is often precluded in many patients. Culture and microscopy of respiratory tract samples are relatively insensitive diagnostic tests. Early detection of IA can lead to specific therapeutic strategies and improved patient outcomes. Breath is a rich and complex sampling medium containing both volatile organic compounds (VOCs) and respiratory droplets carrying non-volatiles, proteins, lipids, viruses and even bacteria. The major advantage of exhaled breath analysis is non-invasiveness, with existing sampling methods already readily available.
The diagnostic or prognostic value of exhaled breath analysis has been evaluated in many respiratory diseases, including asthma, Chronic Obstructive Pulmonary Disease, idiopathic pulmonary fibrosis, as well as in some lung infections such as bacterial pneumonia. In the particular field of aspergillosis diagnosis, using a chromatographic-mass spectrometry analysis of exhaled breath in immunocompromised hosts (organ transplantation, hematological malignancies or HSCT), researchers have been able to identify an exhaled breath metabolic signature (made of β-trans-bergamotene, α-trans-bergamotene, a β-vatirenene-like sesquiterpene, and trans-geranylacetone) that potentially allows the discrimination of probable or proven aspergillosis from other lung infections, with high levels of sensitivity and specificity. Exhaled breath therefore appears as a promising field for the improvement of IA diagnosis, and more broadly of respiratory infections. Volatile organic compound (VOC) detection via thermal desorption/gas chromatography-mass spectrometry has emerged as a promising tool for early diagnosis of IA, however the sample sizes have been limited. As such, the proposed pilot study aims to identify potential VOC biomarkers for both IA and Aspergillus colonization and assess the feasibility of VOCs on breath for the diagnosis of IA in lung transplant recipients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –patients without evidence of Aspergillus colonization or Aspergillus related disease |
| Colonised Aspergillus | – | –patients with Aspergillus colonization |
| Invasive Aspergillus | – | –patients with proven or probably IA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Lung transplant recipient patients undergoing bronchoscopy as a standard of care for suspected invasive fungal disease (IFD) or surveillance appointments will be eligible for screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identifying a statistical relationship between Volatile Organic Compounds detection and the diagnosis of IA by existing International Society for Heart and Lung Transplantation (ISHLT) and MSG/EORTC criteria.
Time frame: 18 months
Identifying a statistical relationship between Volatile Organic Compounds detection and the diagnosis of IA by existing International Society for Heart and Lung Transplantation (ISHLT) and European Organization for Research and Treatment of Cancer/Mycoses Study Group (MSG/EORTC) criteria.
1 secondary outcome
Identifying a statistical relationship between the set of VOCs found in exhaled breath and the diagnosis of Aspergillus colonization as defined by ISHLT criteria
Time frame: 18 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 2024.
- Individual participant dataSharing planned: Undecided
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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.
Shahid Husain, MD,MS principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Aspergillosis, run by Owlstone Ltd at 1 site in Canada.
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 3 Apr 2024. 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 Canada. 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 Shahid Husain, MD.MS ((416) 340-3144, shahid.husain@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying a statistical relationship between Volatile Organic Compounds detection and the diagnosis of IA by existing International Society for Heart and Lung Transplantation (ISHLT) and MSG/EORTC criteria. (time frame: 18 months). 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 2024.