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

NCT02305784 | Completed

• 1 other identifier: Kin_YKL-40_CF
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Pulmonary exacerbation; inflammation; Chitinase; cytokine; Cystic fibrosis related diabetes

Outcome Measures

Primary Outcomes (1)

• Blood concentration of YKL-40 (ng/ml)

  Trajectory of YKL-40 over time

  at every outpatient regular visit over a period of 24 months

Secondary Outcomes (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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will follow the patients (\<18-year-old) for a period of 24 months. In parallel to the measurement of YKL-40 in blood and airway secretions we will monitor other biological parameters (see list below) as well as the BMI, lung function (FEV1/FVC), oxygen saturation and heart rate. We will monitor the glucose metabolism status of the patient (IGT, CFRD) and the number of exacerbations per year as well 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.

You may qualify if:

• man and woman ≥ 18 ans.
• documented CF diagnostic (sweat test or genotype).
• FEV1 ≥ 25%
• Stable: no infection in the last two weeks before the visit.

You may not qualify if:

• \. Exacerbation with respiratory symptoms with ou without hospitalization in the last two weeks 2. Exacerbation treated with IV antibiotics. 3. Patients with B. Cepacia

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

CRIMontreal

Montreal, Quebec, H2W 1R7, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will take a blood sample at each regular clinic visit (3-4/year-no evidence of exacerbation in the past two weeks) as well as at the beginning and the end of an exacerbation treated with IV antibiotics.

MeSH Terms

Conditions

Cystic Fibrosis; Inflammation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yves Berthiaume, MD

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of the clinic and clinical research

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: December 3, 2014
• Study Start: May 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 20, 2018
• Last Updated: January 31, 2019

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)