NCT03437122

Brief Summary

The increasing incidence of chronic respiratory diseases is a public health problem affecting hundreds of thousands of people around the world, including children. Directly exposed to atmospheric aerocontaminants (pollution, allergens), the respiratory tracts represent a complex ecosystem that involves different cells that develop complex interactions with the surrounding connective tissue but also with their rich immune environment and with the microbiota. Although a pathophysiological continuum is postulated between the nasal and bronchial airways in certain diseases, such as allergic diseases, we have identified broad gradients in gene expression between nasal and bronchial samples. This is why cellular variability throughout the respiratory tree needs to be studied in detail. The sequencing of RNAs specifically present in a particular cell, and its comparison with neighboring cells, allows us to document precise cellular contributions and intercellular relationships. Our project will establish protocols to stabilize airway swabs by brushing and/or biopsy, under conditions that will then allow the analysis of gene expression profiles at the single cell level (single cell RNA sequencing). The development of the "single cell" stabilisation and analysis protocol will first be carried out on primary respiratory epithelium cultures and then extended to respiratory specimens taken from healthy volunteers. Through sampling at several levels of the respiratory tree, variations in expression along the tracheobronchial axis will be fully documented. Finally, the interaction between the epithelial compartment and the immunological compartment will be studied by analyzing gene expression on a single cell in different physiopathological contexts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2019

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

January 17, 2018

Last Update Submit

March 20, 2026

Conditions

Respiratory System

Keywords

lung, nasal mucosa, respiratory mucosa

Outcome Measures

Primary Outcomes (1)

  • Number of samples usable

    6 months

Study Arms (1)

All

EXPERIMENTAL
Procedure: Bronchoscopy

Interventions

BronchoscopyPROCEDURE

Multiple level sampling of the respiratory mucosa (cytology brush and biopsies forceps)

All

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age ≥ 18 years and \<40 years
  • non-smoker
  • absence of known acute or chronic disease
  • absence of symptoms suggestive of progressive disease
  • normal clinical examination

You may not qualify if:

  • recent rhino-bronchial infection (\<6 weeks)
  • mental disability
  • pregnant women (a urine test will be performed for all women of childbearing age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

Related Publications (1)

  • Deprez M, Zaragosi LE, Truchi M, Becavin C, Ruiz Garcia S, Arguel MJ, Plaisant M, Magnone V, Lebrigand K, Abelanet S, Brau F, Paquet A, Pe'er D, Marquette CH, Leroy S, Barbry P. A Single-Cell Atlas of the Human Healthy Airways. Am J Respir Crit Care Med. 2020 Dec 15;202(12):1636-1645. doi: 10.1164/rccm.201911-2199OC.

    PMID: 32726565RESULT

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Sylvie LEROY, Dr

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 17, 2018

First Posted

February 19, 2018

Study Start

June 20, 2018

Primary Completion

July 16, 2019

Study Completion

July 16, 2019

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)