Cystic FibrosisMIRDIAMUCONCT02992080
Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis
A study of Cystic Fibrosis, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 12 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Jul 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participation or within the exclusion period of other clinicals trials Patients carrying mutations of clinical varying consequences or non CF-causing mutations
- smokers
Trial locations and contacts
2 sites in 1 country.
France2 sites
Montpellier University Hospital
Montpellier, 34295
Necker Hospital
Paris, 75015
About this study
Official title: Determination of Circulating miRNAs as Diagnostic 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
Read the detailed description
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.
- Conditions
- Cystic Fibrosis
- Being tested
- miRNAs isolation from blood samples of patients and control
- Keywords
- Patient with Cystic Fibrosis, Patient without Cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNAs isolation from blood samples of patients and controlOther
Blood sample collection in specific PAXGene tubes
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis Patients | Other | Not described Receives: Other: miRNAs isolation from blood samples of patients and control |
| Patients without fibrosis cystic | Other | Not described Receives: Other: miRNAs isolation from blood samples of patients and control |
| Cystic fibrosis Patients (secondary use of samples) | Other | Not described Receives: Other: miRNAs isolation from blood samples of patients and control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls
Compare the distributions of miRNAs expression in blood samples of CF patients and to healthy controls
Measured: After blood collection: 2 years
Secondary outcomes (1)
Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status
Compare the distributions of miRNAs expression in blood samples of CF patients with mild lung disease and CF patients with severe lung disease
Measured: After blood collection 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start12 Jul 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline RAYNAL, PharmD, PhD, Principal investigator, Montpellier University Hospital (CHU Montpellier) Montpellier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992080
- Sponsor's protocol ID
- 9548
- Acronym
- MIRDIAMUCO
- Status last verified
- Dec 2021
- First submitted
- 7 Sep 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02992080
- Acronym / sponsor ID
- MIRDIAMUCO / 9548
- Conditions
- Cystic Fibrosis
- Keywords
- Patient with Cystic Fibrosis, Patient without Cystic fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Jul 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis Patients | Other | Other: miRNAs isolation from blood samples of patients and control |
| Patients without fibrosis cystic | Other | Other: miRNAs isolation from blood samples of patients and control |
| Cystic fibrosis Patients (secondary use of samples) | Other | Other: miRNAs isolation from blood samples of patients and control |
Who may qualify
- Ages
- 12 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Participation or within the exclusion period of other clinicals trials Patients carrying mutations of clinical varying consequences or non CF-causing mutations
- smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miRNAs isolation from blood samples of patients and controlBlood sample collection in specific PAXGene tubes | Other | Cystic fibrosis Patients, Cystic fibrosis Patients (secondary use of samples), Patients without fibrosis cystic |
Primary outcome
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
1 secondary outcome
Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status
Time frame: After blood collection 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline RAYNAL, PharmD, PhD principal investigator
Montpellier University Hospital (CHU Montpellier) Montpellier University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cystic Fibrosis, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls (time frame: After blood collection: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.