Kin_YKL_CF: Kinetics of YKL-40 Protein in Serum of Cystic Fibrosis Patients

Sponsor
Institut de Recherches Cliniques de Montreal (Other)
Overall Status
Completed
CT.gov ID
NCT02305784
Collaborator
(none)
188
1
37.7
5

Study Details

Study Description

Brief Summary

YKL-40 is proposed as a biomarker of various inflammatory disease diabetes and lung disease including cystic fibrosis. In those cross-sectional studies, a unique value of YKL-40 is used to correlate with clinical, physiological, or biological determinants of disease severity (like FEV1 for example in lung disease). There is only one longitudinal study that showed a correlation between circulating levels of YKL-40 and the decline of lung function in smokers sampled from the general population. In order to better understand the potential role of YKL-40 in CF pathophysiology, and to determine its potential role as a biomarker of disease evolution, it is essential to proceed with further clinical evaluation. The investigators propose to perform an observational prospective cohort study to determine if variation of YKL-40 concentration over 24 months correlates with the clinical evolution of the patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Observational prospective cohort: The primary objective of the study is to determine if variation of YKL-40 concentration (in blood or sputum) over 24 months will correlate with the biological or clinical condition of the patients. For this study, only patients (FEV1 > 30%) positive for Pseudomonas in the past year will be included, while B Cepacia positive patients will be excluded. There are presently 200 patients meeting these inclusion criteria. The investigators choose to limit the study population to patients with Pseudomonas since they are more likely to have FEV1 changes or clinical evolution during the observation period. The investigators expect a high participation rate since the only obligation for the patients is to provide samples at each visit. A blood (for serum and DNA) and sputum samples will be taken at each regular clinic visit (3-4/year-no evidence of exacerbation in the past two weeks) as well as at the beginning and at the end of an exacerbation treated with IV antibiotics. This will also allow the investigators to determine if there is a change in YKL-40 during an exacerbation. The patients will be followed for a period of 24 months. In parallel to the measurement of YKL-40 in blood and airway secretions, other biological parameters will be monitored (see list below) as well as the BMI, lung function (FEV1/FVC), oxygen saturation and heart rate. The investigators will also monitor the glucose metabolism status of the patient (IGT, CFRD) and the number of exacerbations per year as well as any significant changes in the microbiology status of the patients. A pulmonary exacerbation will be defined as an acute exacerbation of pulmonary symptoms that in the opinion of the CF physician is severe enough to require intravenous antibiotics. The proposed sample size, was shown by power calculation, to be sufficient to demonstrate a meaningful changes in YKL-40 (initial-final) given plausible values of the standard deviation of this difference between patients.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    188 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Chitinase and Cystic Fibrosis Disease Evolution
    Study Start Date :
    May 1, 2015
    Actual Primary Completion Date :
    Jun 1, 2018
    Actual Study Completion Date :
    Jun 20, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Blood concentration of YKL-40 (ng/ml) [at every outpatient regular visit over a period of 24 months]

      Trajectory of YKL-40 over time

    Secondary Outcome Measures

    1. Change of Blood concentration of YKL-40 (ng/ml) during an exacerbation [At the beginning and at the end of an exacerbation during the 24 months of follow-up]

      Variation of YKL-40 during exacerbation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. man and woman ≥ 18 ans.

    2. documented CF diagnostic (sweat test or genotype).

    3. FEV1 ≥ 25%

    4. Stable: no infection in the last two weeks before the visit.

    Exclusion Criteria:
    1. Exacerbation with respiratory symptoms with ou without hospitalization in the last two weeks 2. Exacerbation treated with IV antibiotics. 3. Patients with B. Cepacia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CRIMontreal Montréal Quebec Canada H2W 1R7

    Sponsors and Collaborators

    • Institut de Recherches Cliniques de Montreal

    Investigators

    • Principal Investigator: Yves Berthiaume, MD, Institut de recherches cliniques de Montréal

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yves Berthiaume, Executive Director of the clinic and clinical research, Institut de Recherches Cliniques de Montreal
    ClinicalTrials.gov Identifier:
    NCT02305784
    Other Study ID Numbers:
    • Kin_YKL-40_CF
    First Posted:
    Dec 3, 2014
    Last Update Posted:
    Jan 31, 2019
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Yves Berthiaume, Executive Director of the clinic and clinical research, Institut de Recherches Cliniques de Montreal
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 31, 2019