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Application of an Electronic Nose in the Early Detection of ASpergillosis (AENEAS)

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ClinicalTrials.gov Identifier: NCT01395446
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to establish the accuracy with which the eNose can discriminate patients with invasive pulmonary aspergillosis from controls.

Condition or disease
Pulmonary Invasive Aspergillosis

Study Design

Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Application of an Electronic Nose in the Early Detection of ASpergillosis
Study Start Date : January 2010
Primary Completion Date : July 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
prolonged neutropenic patients
patients that will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia of prolonged duration


Outcome Measures

Primary Outcome Measures :
  1. accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever [ Time Frame: 4 days ]
    The cross-validated accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever, defined as the percentage of correctly classified patients using the leave-one out method


Biospecimen Retention:   Samples Without DNA
BAL

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients that will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia of prolonged duration
Criteria

Inclusion Criteria:

Patients 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

Exclusion Criteria:

  1. a previously diagnosed invasive mycosis
  2. the inability to perform the breathing manoeuvre needed for eNose-analysis of exhaled air
Contacts and Locations

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): NCT01395446


Locations
Netherlands
Department of Hematology, Academic Medical Center
Amsterdam, Netherlands, 1100 DD
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information

Responsible Party: K. de Heer, Drs. K. de Heer, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01395446     History of Changes
Other Study ID Numbers: 28062009
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Aspergillosis
Invasive Pulmonary Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Pulmonary Aspergillosis
Invasive Fungal Infections
Lung Diseases
Respiratory Tract Diseases