Cystic Fibrosis Diagnosis by Analyzing Nasal Brushing

NCT02433132 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2017-09-28

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Virginie Prulière-Escabasse, MD, PhD · Centre Hospitalier Intercommunal of Creteil

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-07-31
Completion
2018-09-30

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02433132 on ClinicalTrials.gov