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Completed

NCT Number: NCT02992080

Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis

The aim of our study is to assess miRNAs expression profiles in the circuling blood of patients with cystic fibrosis and highlight "signatures" that could reflect the pulmonary status of patients

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

12 month–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier University Hospital, Montpellier, France

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About this study

The objective of this project is to study the circulating miRNA profiles in 40 patients with cystic fibrosis (5 samples which are acquired through a secondary use) and 40 healthy individuals to assess whether these biomolecules could be used as markers of the pulmonary disease in cystic fifbosis. Moreover by comparing miRNAs expression level between Cystic fibrosis (CF) patients with severe (n=20) or moderate (n=20) pulmonary impairment, we want to assess whether some of these miRNAs may be used as markers for the severity of CF pulmonary disease. The identification of sensitive and early markers, from a non-invasive sampling could enable more effective and early treatment of CF patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Cystic fibrosis (CF) (MIM#219700) who are compound heterozygous or homozygous for CF causing mutations Healthy controls non -smokers and free pulmonary disease

Exclusion criteria

  • Participation or within the exclusion period of other clinicals trials Patients carrying mutations of clinical varying consequences or non CF-causing mutations
  • smokers

Treatment and study plan

miRNAs isolation from blood samples of patients and control

Other

Blood sample collection in specific PAXGene tubes

Primary outcomes

  1. Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls

    Time frame: After blood collection: 2 years

    Compare the distributions of miRNAs expression in blood samples of CF patients and to healthy controls

Secondary outcomes

  1. Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status

    Time frame: After blood collection 2 years

    Compare the distributions of miRNAs expression in blood samples of CF patients with mild lung disease and CF patients with severe lung disease

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis

Acronym: MIRDIAMUCO

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2016
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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