Invasive AspergillosisAENEASIINCT02106117
Exhaled Breath Analysis in the Early Detection of Aspergillosis
An observational study of Invasive Aspergillosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial summary
Although the clinical outcome in patients with Invasive Aspergillosis (IA) is largely dependent on early initiation of effective treatment with antifungal drugs, diagnosing IA is still a critical problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Aspergillosis
- How many people
- 120 participants
- Where
- 2 sitesNetherlands
- Study dates
- Dec 2012to Mar 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged 18 or older, admitted at the hematology department of the AMC or UMCU, that will undergo treatment for a hematological malignancy expected to result in prolonged neutropenia (neutrophil counts <0.5 x 10 ^9/L for more than seven days).
Who may be able to join
- Patients are:
- aged 18 years or older;
- diagnosed with a hematological malignancy;
- treatment is expected to result in prolonged (>7 days) neutropenia (<0.5 x 10^9/L)
- able to give written and dated informed consent prior to any study specific procedures.
Who cannot join
- Patients are unable to perform the breathing manoeuvre needed for eNose-analysis of exhaled air
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Academic Medical Center
Amsterdam, 1105AZ
University Medical Center Utrecht
Utrecht, 3584CX
About this study
Official title: The Application of an Electronic Nose in the Early Detection of Aspergillosis II
Although the clinical outcome in patients with Invasive Aspergillosis (IA) is largely dependent on early initiation of effective treatment with antifungal drugs, diagnosing IA is still a critical problem. Symptoms are non-specific and available diagnostic tools are either invasive or have low sensitivity and specificity. This often results in a diagnostic delay, with patients developing more extensive disease. Furthermore, as long as IA is present, oncological follow-up treatment is not feasible. Inaccuracy in diagnosing IA can cause serious treatment delay and increased mortality. However, an empirical strategy with prophylactic anti-mould therapy is not feasible considering both possible side effects and costs. In order to safely continue the use of a pre-empirical strategy, improved (non-invasive) diagnostic tools are desirable.
In a pilot study de Heer et al. showed that it is possible to discriminate between patients with IA and their neutropenic controls by exhaled breath analysis using an electronic nose (eNose). In this study the investigators aim to test whether an eNose could be useful as a diagnostic tool in a prospective setting.
Read more
The gold standard in exhaled breath analysis is Gas Chromatography - Mass Spectrometry (GC-MS). This technique enables identification of volatile organic compounds (VOCs) in breath of patients. It is possible that there are Aspergillus specific VOCs in the breath of patients with IA.
The composition of the lung microbiome seems to be an important factor in both health and disease. It is likely that the microbiome of the lung changes in prolonged neutropenia, therefore possibly creating a niche for molds and yeasts. Comparing the microbiome of patients with prolonged neutropenia who develop IA with those who do not, can learn us more about the pathogenesis of this disease. This knowledge could be used to investigate new treatment options for Invasive Aspergillosis.
Hypothesis The investigators hypothesize that airway microbial (viral, bacterial) presence and exhaled molecular profiles as obtained from patients with prolonged neutropenia due to treatment of hematological malignancies, are different between patients who develop IA and patients who do not.
Read the detailed description
Aims
- To compare the exhaled molecular profiles (GC-MS and eNose) between neutropenic patients who develop IA and neutropenic controls.
- To investigate whether exhaled molecular profiles can serve as surrogate to predict IA at an early stage.
- To compare the alterations in the viral/bacterial microbial profiles during the neutropenic episode between patients who develop IA and controls.
- To examine the relationship between microbial and molecular profiles in order to generate mechanistic hypotheses.
- Conditions
- Invasive Aspergillosis
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 |
|---|---|---|
| neutropenic patients | Patients receiving treatment for hematological malignancies expected to result in prolonged neutropenia (neutrophil counts <0.5 x 10 ^9/L for more than seven days). |
What is being measured
The primary outcome is the main question the study is designed to answer.
molecular profiles in exhaled breath
Exhaled molecular profiles (by eNose and GC-MS) and the accuracy with which serial analysis of these profiles can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls in terms of sensitivity, specificity and accuracy of the predictive algorithm.
Breath will be collected twice weekly during the neutropenic episode, resulting in an average of 5 exhaled breath measurements (eNose as well as GC-MS) per patient. Approximately 150 patients will be included for exhaled breath analysis.
Measured: 2 years
Secondary outcomes (1)
Microbiome analysis of throat swabs
The alteration in the distribution of the pulmonary microbial community in neutropenic subjects developing invasive pulmonary aspergillosis compared to neutropenic subjects who do not.
A throatswab will be taken once a week during the neutropenic episode, resulting in an average of 3 swabs per episode. Microbiome analysis will be performed in 60 patients.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startDec 2012
- Primary completionMar 2017
- Study completionMar 2017
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.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Responsible party
- Principal investigator, prof dr M.H.J. van Oers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- M.H.J. van Oers, Prof. dr., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)M.C. Minnema, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106117
- Sponsor's protocol ID
- AENEAS II
- Acronym
- AENEASII
- Status last verified
- Jul 2018
- First submitted
- 10 Jul 2013
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of an Electronic Nose in the Early Detection of Aspergillosis II
- ClinicalTrials.gov ID
- NCT02106117
- Acronym / sponsor ID
- AENEASII / AENEAS II
- Conditions
- Invasive Aspergillosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- Dec 2012
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Apr 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.
Although the clinical outcome in patients with Invasive Aspergillosis (IA) is largely dependent on early initiation of effective treatment with antifungal drugs, diagnosing IA is still a critical problem. Symptoms are non-specific and available diagnostic tools are either invasive or have low sensitivity and specificity. This often results in a diagnostic delay, with patients developing more extensive disease. Furthermore, as long as IA is present, oncological follow-up treatment is not feasible. Inaccuracy in diagnosing IA can cause serious treatment delay and increased mortality. However, an empirical strategy with prophylactic anti-mould therapy is not feasible considering both possible side effects and costs. In order to safely continue the use of a pre-empirical strategy, improved (non-invasive) diagnostic tools are desirable.
In a pilot study de Heer et al. showed that it is possible to discriminate between patients with IA and their neutropenic controls by exhaled breath analysis using an electronic nose (eNose). In this study the investigators aim to test whether an eNose could be useful as a diagnostic tool in a prospective setting.
The gold standard in exhaled breath analysis is Gas Chromatography - Mass Spectrometry (GC-MS). This technique enables identification of volatile organic compounds (VOCs) in breath of patients. It is possible that there are Aspergillus specific VOCs in the breath of patients with IA.
The composition of the lung microbiome seems to be an important factor in both health and disease. It is likely that the microbiome of the lung changes in prolonged neutropenia, therefore possibly creating a niche for molds and yeasts. Comparing the microbiome of patients with prolonged neutropenia who develop IA with those who do not, can learn us more about the pathogenesis of this disease. This knowledge could be used to investigate new treatment options for Invasive Aspergillosis.
Hypothesis The investigators hypothesize that airway microbial (viral, bacterial) presence and exhaled molecular profiles as obtained from patients with prolonged neutropenia due to treatment of hematological malignancies, are different between patients who develop IA and patients who do not.
Detailed description
Aims
- To compare the exhaled molecular profiles (GC-MS and eNose) between neutropenic patients who develop IA and neutropenic controls.
- To investigate whether exhaled molecular profiles can serve as surrogate to predict IA at an early stage.
- To compare the alterations in the viral/bacterial microbial profiles during the neutropenic episode between patients who develop IA and controls.
- To examine the relationship between microbial and molecular profiles in order to generate mechanistic hypotheses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neutropenic patients | – | –Patients receiving treatment for hematological malignancies expected to result in prolonged neutropenia (neutrophil counts <0.5 x 10 ^9/L for more than seven days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 or older, admitted at the hematology department of the AMC or UMCU, that will undergo treatment for a hematological malignancy expected to result in prolonged neutropenia (neutrophil counts <0.5 x 10 ^9/L for more than seven days).
Key inclusion criteria (5 listed)
- aged 18 years or older;
- diagnosed with a hematological malignancy;
- treatment is expected to result in prolonged (>7 days) neutropenia (<0.5 x 10^9/L)
- able to give written and dated informed consent prior to any study specific procedures.
Key exclusion criteria (1 listed)
- Patients are unable to perform the breathing manoeuvre needed for eNose-analysis of exhaled air
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
molecular profiles in exhaled breath
Time frame: 2 years
Exhaled molecular profiles (by eNose and GC-MS) and the accuracy with which serial analysis of these profiles can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls in terms of sensitivity, specificity and accuracy of the predictive algorithm. Breath will be collected twice weekly during the neutropenic episode, resulting in an average of 5 exhaled breath measurements (eNose as well as GC-MS) per patient. Approximately 150 patients will be included for exhaled breath analysis.
1 secondary outcome
Microbiome analysis of throat swabs
Time frame: 3 years
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 3 Jul 2018.
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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.
M.H.J. van Oers, Prof. dr. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
M.C. Minnema, MD PhD principal investigator
UMC Utrecht
2 sites 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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
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 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 3 Jul 2018. 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 Netherlands. 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?
molecular profiles in exhaled breath (time frame: 2 years). 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 Jul 2018.