1. To establish whether serial exhaled breath analysis using eNose can detect invasive pulmonary aspergillosis in patients with prolonged chemotherapy induced neutropenia (neutrophil counts
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Fungal infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
1. Individual biomarkers and proteomic profiles in BAL fluid, exhaled air and
serum predictive for invasive pulmonary aspergillosis, determined by different
mass spectrometry techniques.
2. The alteration in the distribution of the pulmonary microbial community in
neutropenic subjects developing invasive pulmonary aspergillosis compared to
neutropenic subjects who do not.
Background summary
Patients with prolonged chemotherapy-induced neutropenia are at risk for
invasive pulmonary aspergillosis (IPA). Incidence of IPA in this population is
somewhere around 8-14% and mortality is high. Diagnosing IPA is complex,
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 and in the meantime, increasing
the mortality. Therefore, improved (non-invasive) diagnostic tools are
desirable. In several diseases analysis of exhaled breath (using eNose) showed
to be a promising diagnostic tool. This is potentially a fast, easy-to-perform
and cheap addition to the diagnostic arsenal, improving diagnostic accuracy and
reducing the mortality of the infectious complications associated with the
treatment of hematological diseases.
Study objective
1. To establish whether serial exhaled breath analysis using eNose can detect
invasive pulmonary aspergillosis in patients with prolonged chemotherapy
induced neutropenia (neutrophil counts <0.5 x 10^9 for more than 7 days).
2. To establish whether serial exhaled breath analysis in this group of
patients can detect invasive pulmonary aspergillosis at an earlier time point
than using the current state-of-the-art diagnostic strategy.
3. To find specific biomarkers in serum, exhaled breath condensate, serial
collected exhaled breath and broncho-alveolar lavage fluid by mass
spectrometry, aimed to accurately diagnose invasive pulmonary aspergillosis.
4. To construct an airway microbiome in patients with prolonged neutropenia at
different time points, comparing patients who develop invasive pulmonary
aspergillosis with neutropenic patients who do not, in order to get more
insights in the pathogenesis of invasive pulmonary aspergillosis.
Study design
Single center prospective cohort study
Study burden and risks
In this study there are no major risks and/or discomforts involved; discomfort
for the patient will be minimized by the involvement of only qualified
professionals in the procedures. The patients themselves will not directly
benefit from participating in this investigation. However, the population may
benefit from this study in the future if these novel diagnostic procedures
(f.e. exhaled breath analysis) prove to be applicable in clinical settings. As
such, we consider the balance between risks and discomfort for patients (low)
and benefit for the future population (potentially high) acceptable.
Meibergdreef 9
1105 AZ 1105AZ
NL
Meibergdreef 9
1105 AZ 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- 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), e.g. induction or consolidation treatment for AML or ALL, a myeloablative allogeneic hematopoietic stem cell transplantation, or a cord blood or haploidentical stem cell transplantation;
Exclusion criteria
- Patients are unable to perform the breathing manouevre needed for eNose-analysis of exhaled air
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL41287.018.12 |