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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01572870
First received: April 4, 2012
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

Title: Duplication in 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 assesed for pulmonary function tests (PFT), sputum cultures, and blood tests for: CHIT1 duplication, IgE and Eosinophils levels. Part of the patients will be assesed for RAST, skin prick test.

Primary outcome measure is the difference in CHIT1 genotyping between the groups.


Condition
Cystic Fibrosis
Chit1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Duplication in CHIT1 Gene and the Risk for Aspergillus Lung Disease in CF Patients

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • CHIT1 genotyping [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    In peripheral blood.


Secondary Outcome Measures:
  • IgE [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    peripheral blood count

  • Eosinophils [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    peripheral blood count

  • skin test for aspergillus [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    skin prick test

  • galactomanan [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    peripheral blood count

  • pulmonary function test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    spirometry

  • RAST test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Radioallergosorbent test (RAST) for molds


Enrollment: 40
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

Title: Duplication in 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 devided 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 assesed 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 Galactomanan.

The primary outcome measure is the difference in CHIT1 genotyping between the groups.

  Eligibility

Ages Eligible for Study:   3 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

40 Cystic Fibrosis patients: Group 1: 22 CF patients who had neither ABPA nor Aspergillus infection in the past.

Group 2: 12 CF patients with persistent Aspergillus infection, without ABPA. Group 3: 6 CF patients with current or past ABPA

Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Cystic Fibrosis.

Exclusion Criteria:

  • Inability to produce sputum, or previous history of lung transplantation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572870

Locations
Israel
Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Lea Bentur, Prof. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01572870     History of Changes
Other Study ID Numbers: 450-10 CTIL, Chit 1
Study First Received: April 4, 2012
Last Updated: April 5, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Chit1
Cystic Fibrosis
Allergic Bronchopulmonary Aspergillosis (ABPA)
Aspergillus

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Lung Diseases
Pancreatic Diseases
Digestive System Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013