NCT02992080

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

3.9 years

First QC Date

September 7, 2016

Last Update Submit

December 30, 2021

Conditions

Cystic Fibrosis

Keywords

Patient with Cystic FibrosisPatient without Cystic fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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

    After blood collection: 2 years

Secondary Outcomes (1)

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

    After blood collection 2 years

Study Arms (3)

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

Interventions

miRNAs isolation from blood samples of patients and controlOTHER

Blood sample collection in specific PAXGene tubes

Cystic fibrosis PatientsCystic fibrosis Patients (secondary use of samples)Patients without fibrosis cystic

Eligibility Criteria

Age12 Months - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montpellier University Hospital

Montpellier, 34295, France

Location

Necker Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Caroline RAYNAL, PharmD, PhD

    Montpellier University Hospital (CHU Montpellier) Montpellier University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

December 14, 2016

Study Start

July 12, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

January 3, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)