Duplication in CHIT1 Gene and the Risk for Aspergillus Lung Disease in CF Patients
NCT ID: NCT01572870
Last Updated: 2016-06-28
Study Results
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Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2010-12-31
2011-09-30
Brief Summary
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Aim: To evaluate the link between CHIT1 duplication in CF patients and the predisposition to ABPA or persistent Aspergillus infection.
Patients: 40 CF patients. Design: Observational, single visit. Methods: All patients will be assessed for pulmonary function tests (PFT), sputum cultures, and blood tests for: CHIT1 duplication, immunoglobulin E (IgE) and Eosinophils levels. Part of the patients will be assessed for RAST, skin prick test.
Primary outcome measure is the difference in CHIT1 genotyping between the groups.
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Detailed Description
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Introduction: Chitinases are the enzymes that digest the chitin polymer. Plants use CHIT1 as an important innate defense mechanism against fungi. CHIT1 is the major chitinase in the human airways.Variation in the coding region, with 24-bp duplication allele results in a reduced CHIT1 activity. Recently, CHIT1 duplication was found in 6/6 patients with severe asthma and fungal sensitization Aspergillus often persists in the respiratory tract of patients with Cystic Fibrosis (CF) and may cause allergic broncho pulmonary aspergillosis (ABPA).
Aim: to evaluate the link between CHIT1 duplication in CF patients and the predisposition to ABPA or persistent Aspergillus infection.
Patients: 40 CF patients divided to three groups .Group 1: patients who have neither ABPA nor Aspergillus infection in the past (the control group).Group 2: patients with persistent Aspergillus infection, without ABPA. Group 3: patients with current or past ABPA.
Design: Observational, single visit. Methods: All patients will be assessed for pulmonary function tests (PFT), sputum cultures, and blood tests for: CHIT1 duplication, IgE and Eosinophils levels.
Patient's characteristics including demographics, CF mutations, pancreatic status and sweat test will be derived from the charts.
Patients with ABPA as well as Aspergillus infection had also radioallergosorbent test (RAST) for molds, as well as skin prick test for Aspergillus and blood Galactomannan.
The primary outcome measure is the difference in CHIT1 genotyping between the groups.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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No ABPA nor Aspergillus infection
CF patients who had neither ABPA nor Aspergillus infection in the past (the control group)
No interventions assigned to this group
persistent Aspergillus infection, without ABPA
CF patients with persistent Aspergillus infection, without ABPA.
No interventions assigned to this group
Current or past ABPA infection
CF patients with current or past ABPA
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Years
50 Years
ALL
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Principal Investigators
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Lea Bentur, Prof.
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Rambam health care campus
Haifa, , Israel
Countries
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References
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Livnat G, Bar-Yoseph R, Mory A, Dagan E, Elias N, Gershoni R, Bentur L. Duplication in CHIT1 gene and the risk for Aspergillus lung disease in CF patients. Pediatr Pulmonol. 2014 Jan;49(1):21-7. doi: 10.1002/ppul.22749. Epub 2013 Jan 28.
Other Identifiers
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Chit 1
Identifier Type: -
Identifier Source: secondary_id
450-10 CTIL
Identifier Type: -
Identifier Source: org_study_id
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