Cystic Fibrosis Diagnosis by Analyzing Nasal Brushing (MUCO-BROCC)
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|ClinicalTrials.gov Identifier: NCT02433132|
Recruitment Status : Unknown
Verified September 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : May 4, 2015
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Atypical Form of Cystic Fibrosis||Other: Nasal brushing||Not Applicable|
Autosomal recessive, CF is caused by mutations in the CFTR gene whose nature determines the clinical expression and severity of the disease affecting mainly the respiratory, digestive and genital. Respiratory pathology is mainly responsible for the morbidity and mortality of patients with cystic fibrosis. CFTR, which is ion channel carrying chlorine, plays an essential role in respiratory disease through its involvement in the changes of surface liquid covering the respiratory epithelial cells.
Currently the measurement of nasal potential difference in vivo (DPN) can cause arguments electrophysiological diagnosis of cystic fibrosis (chlorine transport default) for patients with atypical form but can be rendered difficult or non-interpretable by the lack of cooperation of the patient (especially in the children who do not support the presence of the probe into the nose) or mostly due to poor local conditions related to infectious diseases rhino sinus of these patients.
It is necessary to develop new and more reliable diagnostic tests for the detection of cases of atypical cystic fibrosis. The study of ion transport from nasal epithelial cells collected by brushing (NBC) in the diagnosis of atypical forms of cystic fibrosis is tested in this trial as a new diagnostic test.
This research will focus on three groups:
- Of patients with cystic fibrosis adults.
- adult patients with atypical form
- people who do not have cystic fibrosis
Depending on the patient group, there will be only one CCBN or CCBN and DPN or CCBN and DPN and genetic analysis to verify the absence of mutation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Ion Transport From Nasal Epithelial Cells Collected by Brushing (CCBN) in the Diagnosis of Atypical Forms of Cystic Fibrosis|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||September 2018|
Diagnostic test will be perform on cell from nasal brushing
Other: Nasal brushing
The CCBN test is to evaluate the ion transport in the nasal epithelial cells taken from a subject by brushing the inferior turbinate with a mini-brush after local anesthesia. Analysis of ion transport is carried out ex vivo on the primary culture of nasal epithelial cells after brushing
- Quality of the CCBN test [ Time Frame: 14 days after nasal brushing ]
The primary endpoint is composite. The diagnostic quality of the test CCBN is the analysis of nasal epithelial cells:
- in basal short-circuit current,
- in amiloride-sensitive current corresponding to ENaC
- cyclic AMP-dependent current corresponding to CFTR
- Nasal potential difference [ Time Frame: 14 days after nasal brushing ]
The nasal potential difference will be evaluated :
- in basal,
- after infusion of a solution of amiloride,
- after infusion of a solution without amiloride chloride,
- after infusion of a solution of amiloride and isoproterenol (agonist of cAMP).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433132
|Contact: Virginie Prulière-Escabasse, MD, PhD||(0)145175597 ext +email@example.com|
|Contact: Candy Estevez, CRA||(0)149813752 ext +firstname.lastname@example.org|
|Centre Hospitalier Intercommunal de Créteil||Recruiting|
|Creteil, France, 94010|
|Principal Investigator:||Virginie Prulière-Escabasse, MD, PhD||Centre Hospitalier Intercommunal of Creteil|