NCT04204291

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
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

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

December 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

June 23, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

December 17, 2019

Last Update Submit

February 5, 2024

Conditions

Keywords

lungnasal mucosarespiratory 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

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \<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

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

December 17, 2019

First Posted

December 18, 2019

Study Start

June 23, 2020

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations