Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis
| Tracking Information | |||||
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| First Received Date ICMJE | November 23, 2010 | ||||
| Last Updated Date | June 4, 2012 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC) [ Time Frame: 15 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The identification of biomarkers for IPA in EBC [ Time Frame: 15 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01247142 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate. |
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| Detailed Description | Invasive pulmonary aspergillosis (IPA) is a life-threatening infection in immunocompromised patients. The poor prognosis of the disease is partly attributed to difficulties encountered with the diagnosis of this infection. Invasive sampling procedures are often precluded in these patients. In addition, conventional diagnostic techniques lack sensitivity. Recently there has been increasing interest in the investigation of the lungs by noninvasive means including measurement of biomarkers in exhaled breath (e.g. NO) and those found in the cooled and condensed exhalate,termed EBC. It has been demonstrated that a measurable fraction of the EBC in healthy subjects is derived from aerosolized airway lining fluid. The presence of biomarkers for IPA will be investigated in EBC of patients with IPA, compared to controls. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: exhaled breath condensate |
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| Sampling Method | Probability Sample | ||||
| Study Population | Hospitalized adult patients of the department of Hematology, University Hospital, Leuven, Belgium |
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| Condition ICMJE | Invasive Pulmonary Aspergillosis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01247142 | ||||
| Other Study ID Numbers ICMJE | S52756 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Edith Vermeulen, Universitaire Ziekenhuizen Leuven | ||||
| Study Sponsor ICMJE | Universitaire Ziekenhuizen Leuven | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Universitaire Ziekenhuizen Leuven | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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