Ignite Creation Date:
2024-05-06 @ 2:41 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02106117
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2013-07-10
Brief Title:
Exhaled Breath Analysis in the Early Detection of Aspergillosis
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
The Application of an Electronic Nose in the Early Detection of Aspergillosis II
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AENEASII
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
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
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 viralbacterial 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
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 viralbacterial 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None