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Duplication in CHIT1 Gene and the Risk for Aspergillus Lung Disease in CF Patients

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Completed
CT.gov ID
NCT01572870
Collaborator
(none)
40
Enrollment
1
Location
9
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Title: Duplication in Chitotriosidase (CHIT1) Gene and the Risk for Aspergillus Lung Disease in CF Patients.

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Title: Duplication in Chitotriosidase (CHIT1) Gene and the Risk for Aspergillus Lung Disease in CF Patients.

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Duplication in CHIT1 Gene and the Risk for Aspergillus Lung Disease in CF Patients
    Study Start Date :
    Dec 1, 2010
    Actual Primary Completion Date :
    Mar 1, 2011
    Actual Study Completion Date :
    Sep 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    No ABPA nor Aspergillus infection

    CF patients who had neither ABPA nor Aspergillus infection in the past (the control group)
    persistent Aspergillus infection, without ABPA

    CF patients with persistent Aspergillus infection, without ABPA.
    Current or past ABPA infection

    CF patients with current or past ABPA

    Outcome Measures

    Primary Outcome Measures

    1. CHIT1 genotyping [Baseline]

      In peripheral blood.

    Secondary Outcome Measures

    1. IgE [Baseline]

      peripheral blood count

    2. Eosinophils [Baseline]

      peripheral blood count

    3. skin test for aspergillus [Baseline]

      skin prick test

    4. galactomannan [Baseline]

      peripheral blood count

    5. pulmonary function test [Baseline]

      spirometry

    6. RAST test [Baseline]

      Radioallergosorbent test (RAST) for molds

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Confirmed diagnosis of Cystic Fibrosis.
    Exclusion Criteria:
    • Inability to produce sputum, or previous history of lung transplantation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam health care campus Haifa Israel

    Sponsors and Collaborators

    • Rambam Health Care Campus

    Investigators

    • Principal Investigator: Lea Bentur, Prof., Rambam Health Care Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rambam Health Care Campus
    ClinicalTrials.gov Identifier:
    NCT01572870
    Other Study ID Numbers:
    • 450-10 CTIL
    • Chit 1
    First Posted:
    Apr 6, 2012
    Last Update Posted:
    Jun 28, 2016
    Last Verified:
    Jun 1, 2016
    Keywords provided by Rambam Health Care Campus
    Chit1
    Cystic Fibrosis
    Allergic Bronchopulmonary Aspergillosis (ABPA)
    Aspergillus
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Lung Diseases
    Fibrosis

    Study Results

    No Results Posted as of Jun 28, 2016