Trial record 3 of 102 for:    "Aspergillosis"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01395446
First received: June 29, 2011
Last updated: July 14, 2011
Last verified: June 2011
  Purpose

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


Condition
Pulmonary Invasive Aspergillosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Application of an Electronic Nose in the Early Detection of ASpergillosis

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: January 2010
Groups/Cohorts
prolonged neutropenic patients
patients that will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia of prolonged duration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395446

Locations
Netherlands
Department of Hematology, Academic Medical Center Recruiting
Amsterdam, Netherlands, 1100 DD
Contact: K. de Heer, M.D.    +31.20.5665785    K.deHeer@amc.nl   
Contact: M.H. van Oers, Prof. dr.    +31.20.5665785    m.h.vanoers@amc.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: Prof. dr. M.H.J. van Oers, Department of Hematology, Academic Medical Center
ClinicalTrials.gov Identifier: NCT01395446     History of Changes
Other Study ID Numbers: 28062009
Study First Received: June 29, 2011
Last Updated: July 14, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on August 28, 2014