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Trial record 14 of 200 for:    aspergillosis

Exhaled Breath Analysis in the Early Detection of Aspergillosis (AENEASII)

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ClinicalTrials.gov Identifier: NCT02106117
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
prof dr M.H.J. van Oers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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. 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.


Condition or disease
Invasive Aspergillosis

Detailed Description:

Aims

  1. To compare the exhaled molecular profiles (GC-MS and eNose) between neutropenic patients who develop IA and neutropenic controls.
  2. To investigate whether exhaled molecular profiles can serve as surrogate to predict IA at an early stage.
  3. To compare the alterations in the viral/bacterial microbial profiles during the neutropenic episode between patients who develop IA and controls.
  4. To examine the relationship between microbial and molecular profiles in order to generate mechanistic hypotheses.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Application of an Electronic Nose in the Early Detection of Aspergillosis II
Study Start Date : December 2012
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Group/Cohort
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).



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Microbiome analysis of throat swabs [ Time Frame: 3 years ]

    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.



Biospecimen Retention:   Samples With DNA
Throat Swabs for microbiome analysis Serum samples for Galactomannan detection.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • Patients are unable to perform the breathing manoeuvre needed for eNose-analysis of exhaled air

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106117


Locations
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Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105AZ
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
UMC Utrecht
Investigators
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Principal Investigator: M.H.J. van Oers, Prof. dr. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: M.C. Minnema, MD PhD UMC Utrecht

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Responsible Party: prof dr M.H.J. van Oers, prof. dr. M.H.J. van Oers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02106117     History of Changes
Other Study ID Numbers: AENEAS II
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Aspergillosis
Mycoses