Cystic FibrosisNCT01572870
Duplication in CHIT1 Gene and the Risk for Aspergillus Lung Disease in CF Patients
An observational study of Cystic Fibrosis and Chit1, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 50 years
- Conditions the study is for
- Cystic Fibrosis, Chit1
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Confirmed diagnosis of Cystic Fibrosis.
Who cannot join
- Inability to produce sputum, or previous history of lung transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Chit1
- Keywords
- Chit1, Cystic Fibrosis, Allergic Bronchopulmonary Aspergillosis (ABPA), Aspergillus
- Medical subject headings
- Cystic Fibrosis, Aspergillosis, Allergic Bronchopulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
CHIT1 genotyping
In peripheral blood.
Measured: Baseline
Secondary outcomes (6)
IgE
peripheral blood count
Measured: Baseline
Eosinophils
peripheral blood count
Measured: Baseline
skin test for aspergillus
skin prick test
Measured: Baseline
galactomannan
peripheral blood count
Measured: Baseline
pulmonary function test
spirometry
Measured: Baseline
RAST test
Radioallergosorbent test (RAST) for molds
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lea Bentur, Prof., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572870
- Sponsor's protocol ID
- 450-10 CTIL
- Other IDs
- Chit 1
- Status last verified
- Jun 2016
- First submitted
- 4 Apr 2012
- Last updated
- 28 Jun 2016
- Results posted
- No
Publications
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.
PubMed 23359515
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duplication in CHIT1 Gene and the Risk for Aspergillus Lung Disease in CF Patients
- ClinicalTrials.gov ID
- NCT01572870
- Acronym / sponsor ID
- 450-10 CTIL
- Conditions
- Cystic Fibrosis, Chit1
- Keywords
- Chit1, Cystic Fibrosis, Allergic Bronchopulmonary Aspergillosis (ABPA), Aspergillus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Confirmed diagnosis of Cystic Fibrosis.
Key exclusion criteria (1 listed)
- Inability to produce sputum, or previous history of lung transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CHIT1 genotyping
Time frame: Baseline
In peripheral blood.
6 secondary outcomes
IgE
Time frame: Baseline
Eosinophils
Time frame: Baseline
skin test for aspergillus
Time frame: Baseline
galactomannan
Time frame: Baseline
pulmonary function test
Time frame: Baseline
RAST test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Derived from this study: PubMed 23359515Livnat 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.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Bentur, Prof. principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Chit1, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHIT1 genotyping (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.