Application of an Electronic Nose in the Early Detection of ASpergillosis

NCT ID: NCT01395446

Last Updated: 2015-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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Conditions

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Pulmonary Invasive Aspergillosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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prolonged neutropenic patients

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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K. de Heer

Drs. K. de Heer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Hematology, Academic Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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28062009

Identifier Type: -

Identifier Source: org_study_id

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