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The AENEAS study: the Application of an Electronic Nose in the Early detection of ASpergillosis.


- candidate number6889
- NTR NumberNTR2177
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jan-2010
- Secondary IDs09/212 AENEAS
- Public TitleThe AENEAS study: the Application of an Electronic Nose in the Early detection of ASpergillosis.
- Scientific TitleThe AENEAS study: the Application of an Electronic Nose in the Early detection of ASpergillosis.
- ACRONYMthe AENEAS study
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedInvasive pulmonary aspergillosis
- Inclusion criteriaPatients that:
1. Are 18 years of age or older;
2. Will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia (according to CTCAE 3.0, i.e. <0.5 x 109 neutrophils/L) of prolonged duration (i.e., more than 7 days), e.g. hematopoietic stem cell transplantation or induction/consolidation treatment for acute myeloid leukaemia;
3. Have given written informed consent.

If the neutropenic episode is part of a sequence of prolonged neutropenias, the informed consent will apply to all neutropenic episodes. The moment anti-mold treatment is started, the patient will go off-protocol after analysis of exhaled air using the eNose.
- Exclusion criteria1. A previously diagnosed invasive mycosis;
2. The inability to perform the breathing manoeuvre needed for eNose-analysis of exhaled air.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2010
- planned closingdate1-okt-2012
- Target number of participants90
- InterventionsExhaled breath analysis using an electronic nose and gas chromatography-mass spectometry.
- Primary outcomeThe accuracy with which an eNose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever, as measured by the cross-validated values of the sensitivity, specificity and accuracy of the predictive algorithm.
- Secondary outcomeThe accuracy in discriminating neutropenic controls with fever from healthy volunteers using the algorithm derived for the primary endpoint, as measured by the cross-validated values of the sensitivity, specificity and accuracy of the predictive algorithm.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Koen Heer, de
- CONTACT for SCIENTIFIC QUERIES Koen Heer, de
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryIntroduction
There is a need for new diagnostic methods to facilitate earlier diagnosis and treatment of invasive pulmonary mycosis (IPM) during prolonged chemotherapy-induced neutropenia (PCIN). Exhaled breath analysis could fulfill this need.

Objective
Before studying serial samples during neutropenia, we will first establish the accuracy of exhaled breath analysis to discriminate patients with invasive pulmonary aspergillosis (IPA), the most frequent cause of IPM, from neutropenic controls with fever.

Study design
Single center study with a prospective cohort design. Patients will be sampled once.

Population
Patients that will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia for more than 7 days (PCIN).
Cases: Patients with probable or proven IPA and a positive galactomannan assay on bronchoalveolar lavage (BAL).
Controls: Patients with fever but no possible, probable or proven IPM and no positive galactomannan assay performed on serum and BAL.

Diagnostic intervention
Exhaled breath analysis using an electronic nose (eNose) and gas chromatography-mass spectrometry (GC-MS). GC-MS will be used to unravel the molecular mechanisms by which the eNose detects aspergillosis.

Primary endpoint
The accuracy with which an eNose can discriminate between cases and controls as measured by the cross-validated accuracy of the predictive algorithm. Raw data are analysed by discriminant analysis on principal component reduction after which the results will be validated using the “leave-one-out” method.

Sample size
Our aim is to include 125 neutropenic episodes in 80 patients resulting in 10 cases and 10 controls.

Time line
Accrual will take an estimated 18 months, data analysis and writing the publication 6 months. During the accrual we will in parallel perform additional research in vitro and in CF patients for our GC-MS analyses.

Economic evaluation
A limited economic evaluation will be performed by modelling the diagnosis of IPA using a decision tree. The cost and accuracy of various combinations of diagnostic procedures will be determined. We will establish whether the addition of the eNose to the non-invasive work-up of suspected IPA obviates BAL without a loss in health.
- Main changes (audit trail)
- RECORD16-jan-2010 - 7-feb-2010


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