the Application of an Electronic Nose in the Early detection of Aspergillosis II

Completed

• Conditions: Aspergillosis; Invasive Pulmonary Aspergillosis; 10018849; 10017528; 10024970

• Registration Number: NL-OMON39283
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Exhaled molecular profiles (by eNose and GC-MS) and the accuracy with which<br /><br>serial analysis of these profiles can discriminate between patients with<br /><br>probable or proven invasive pulmonary aspergillosis and neutropenic controls in<br /><br>terms of sensitivity, specificity and accuracy of the predictive algorithm. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> 1. Individual biomarkers and proteomic profiles in BAL fluid, exhaled air and<br /><br>serum predictive for invasive pulmonary aspergillosis, determined by different<br /><br>mass spectrometry techniques.<br /><br>2. The alteration in the distribution of the pulmonary microbial community in<br /><br>neutropenic subjects developing invasive pulmonary aspergillosis compared to<br /><br>neutropenic subjects who do not. </p><br>