NCT02433132

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

3.3 years

First QC Date

April 29, 2015

Last Update Submit

September 27, 2017

Conditions

Cystic FibrosisAtypical Form of Cystic Fibrosis

Keywords

Cystic fibrosisAdultsAtypical formNasal brushingEpithelial cellsIon transport

Outcome Measures

Primary Outcomes (1)

  • Quality of the CCBN test

    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

    14 days after nasal brushing

Secondary Outcomes (1)

  • Nasal potential difference

    14 days after nasal brushing

Study Arms (1)

Diagnostic test

OTHER

Diagnostic test will be perform on cell from nasal brushing

Other: Nasal brushing

Interventions

Nasal brushingOTHER

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

Diagnostic test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

RECRUITING

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

  • Virginie Prulière-Escabasse, MD, PhD

    Centre Hospitalier Intercommunal of Creteil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginie Prulière-Escabasse, MD, PhD

CONTACT

(0)145175597virginie.escabasse@chicreteil.fr

Candy Estevez, CRA

CONTACT

(0)149813752candy.estevez@hmn.aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 4, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations

FR(1)