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

June 27, 2016 updated by: Rambam Health Care Campus

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • Confirmed diagnosis of Cystic Fibrosis.

Exclusion Criteria:

  • Inability to produce sputum, or previous history of lung transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHIT1 genotyping
Time Frame: Baseline
In peripheral blood.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IgE
Time Frame: Baseline
peripheral blood count
Baseline
Eosinophils
Time Frame: Baseline
peripheral blood count
Baseline
skin test for aspergillus
Time Frame: Baseline
skin prick test
Baseline
galactomannan
Time Frame: Baseline
peripheral blood count
Baseline
pulmonary function test
Time Frame: Baseline
spirometry
Baseline
RAST test
Time Frame: Baseline
Radioallergosorbent test (RAST) for molds
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 450-10 CTIL
  • Chit 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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