Biomarker for Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-20

Study Completion Date

2022-12-31

Brief Summary

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International, multicenter, observational, longitudinal study to identify biomarker/s for Cystic fibrosis and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s

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Detailed Description

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Cystic fibrosis (CyFi) is a progressive hereditary disease with the prevalence of 1 in 2500. CyFi is an autosomal recessive disease caused by pathogenic variant/s in the CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) gene encoding Cftr protein.

CyFi causes chronic respiratory damage. Pulmonary findings occur already in infancy, which raises questions whether obstruction might be congenital. Thick, sticky mucus clogs the airways, reduces muco-ciliary clearance and leads to problems with breathing and recurrent bacterial (Pseudomonas aeruginosa) infections, which causes over time the formation of scar tissue (fibrosis) and cysts in the lungs.There is no cure for CyFi; however, symptomatic treatment can help relieve symptoms.

The aim of this study is to identify biomarkers for Cystic fibrosis disease and to explore their clinical robustness, specificity, and long-term variability. An ideal biomarker plays an essential role in the early diagnosis, prediction and therapeutic monitoring of a specific disorder.

Conditions

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Chronic Nasal Congestion Lung Infection Breathlessness Clubbing Toes Meconium Ileus Failure to Thrive Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants genetically diagnosed with Cystic fibrosis

Participants diagnosed with Cystic fibrosis aged between 2 months and 50 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Informed consent is obtained from the participant or the parent/ legal guardian
* The participant is aged between 2 months and 50 years
* The diagnosis of Cystic fibrosis is genetically confirmed by CENTOGENE

Exclusion Criteria

* Informed consent is not obtained from the participant or from the parent/ legal guardian
* The participant is younger than 2 months or older than 50 years
* The diagnosis of Cystic fibrosis is not genetically confirmed by CENTOGENE

Minimum Eligible Age

2 Months

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No