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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The diagnosis of CF is currently based on the discovery of two CFTR gene mutations and / or a positive sweat test (> 60mmol / l). A significant number of patients with atypical cystic fibrosis (chronic sino-pulmonary disease with a single mutation in the CFTR gene and / or a test of the intermediate sweat between 30 and 60 mmol / l) undetected by these techniques are behind specialized care while irreversible lung damage is already existed. Currently, the measurement of nasal potential difference in vivo (DPN), which evaluates the transportation of chlorine in the nasal epithelium with an electrode, is proposed for the diagnosis of atypical forms. However DPN dependent nasal local conditions when analysing do not always offer the possibility of concluding the diagnosis of cystic fibrosis. It is necessary to develop new and more reliable diagnostic tests for the detection of cases of atypical cystic fibrosis. The authors propose to develop a new diagnostic technique based on the study of bioelectric properties of a preparation of nasal cells of the subject obtained by brushing and placed in primary culture (CCBN).

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Atypical Form of Cystic Fibrosis Other: Nasal brushing Not Applicable

Detailed Description:

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:

  1. Of patients with cystic fibrosis adults.
  2. adult patients with atypical form
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Diagnostic test
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For patients with cystic fibrosis and those with atypical form:

    • Inclusion at least 30 days after a general or local infection of the upper airways

  • For controls:

    • No history or Sino-pulmonary pathology and negative identification of mutations in the CFTR gene

  • For all subjects involved in research:

    • Information and obtaining informed consent of the subjects.
    • Age ≥ 18 years
    • affiliation to a social security scheme or of such a regime

Exclusion Criteria:

  • For all participants :

    • Taking a per os corticoids or topical corticosteroid treatment in the nose in the month preceding the nasal brushing or measurement of nasal potential difference
    • ORL surgical history of under 2 months
    • cauterization of the inferior turbinate of under 2 months
    • Hypersensitivity to local anesthetics of the amide (such as lidocaine) or with one of the components, including methyl parahydroxybenzoate contained in the excipient.
    • Porphyria.
    • Epilepsy not controlled by treatment.

Information from the National Library of Medicine

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


Contacts
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Contact: Virginie Prulière-Escabasse, MD, PhD (0)145175597 ext +33 virginie.escabasse@chicreteil.fr
Contact: Candy Estevez, CRA (0)149813752 ext +33 candy.estevez@hmn.aphp.fr

Locations
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France
Centre Hospitalier Intercommunal de Créteil Recruiting
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Virginie Prulière-Escabasse, MD, PhD Centre Hospitalier Intercommunal of Creteil
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02433132    
Other Study ID Numbers: P120913
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cystic fibrosis
Adults
Atypical form
Nasal brushing
Epithelial cells
Ion transport
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases