NCT02305784|Completed
Kinetics of YKL-40 Protein in Serum of Cystic Fibrosis Patients
Kin_YKL_CF
Chitinase and Cystic Fibrosis Disease Evolution
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Kin_YKL_CF
Chitinase and Cystic Fibrosis Disease Evolution
Sponsor study identifier
observational
188
1 country
1
Study Start
May 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 1, 2018
Actual (reported)Study Completion
June 20, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 20, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 11, 2014
Actual (reported)December 3, 2014
Actual (reported)May 2015
Date type not reportedThis date has not been verified as actual or estimated.
June 1, 2018
Actual (reported)June 20, 2018
Actual (reported)Blood concentration of YKL-40 (ng/ml)
Trajectory of YKL-40 over time
at every outpatient regular visit over a period of 24 months
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
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.
CRIMontreal
Montreal, Quebec, H2W 1R7, Canada
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.
Yves Berthiaume, MD
Institut de Recherches Cliniques de Montreal
188 participants (actual enrollment reported by the registry).
First Submitted
November 11, 2014
First Posted
December 3, 2014
Study Start
May 2015
Date type not reportedThis date has not been verified as actual or estimated.
Safety Study of Fenretinide in Adult Patients With Cystic Fibrosis
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2018
Actual (reported)Study Completion
June 20, 2018
Actual (reported)Last Updated
January 31, 2019
Record last verified: 2017-07
not possible since the consent form did not include the possibility to share data with other investigators.
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Source: ClinicalTrials.gov.
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