NCT03250897

Brief Summary

The aim of the study is to investigate by flow cytometry the phenotype of alveolar macrophages (AMs) isolated from patients with non-infectious lung diseases.

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
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

August 11, 2017

Last Update Submit

August 11, 2017

Conditions

Lung Diseases

Keywords

Alveolar macrophagesBlood monocyte-derived macrophagesFACS analysisBroncho-alveolar lavage fluidsNon-infectious lung diseases

Outcome Measures

Primary Outcomes (1)

  • To investigate by flow cytometry the phenotype of alveolar macrophages (AMs) isolated from broncho-alveolar lavage fluids of patients with non-infectious lung diseases.

    Characterization of membrane proteins by multi-staining flow cytometry (FACS analysis)

    1 year

Secondary Outcomes (1)

  • To compare the phenotypic profile of AMs from broncho-alveolar lavage fluids of patients with non-infectious lung diseases to that of blood monocyte-derived macrophages differentiated in the presence of GM-CSF or M-CSF and obtained from healthy donors

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by non-infectious lung diseases older than 18 years

You may qualify if:

  • Patients affected by non-infectious lung diseases and for whom a broncho-alveolar lavage is scheduled for their medical care in the pulmonary division
  • Patient Information leaflet provided
  • Written informed consent of the patient

You may not qualify if:

  • A suspected respiratory infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pneumology Division

Rennes, 35033, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Broncho-alveolar lavage fluids of patients with non-infectious lung diseases

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Stéphane Jouneau, Professor

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane Jouneau, Professor

CONTACT

0299282481stephane.jouneau@chu-rennes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 16, 2017

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

September 1, 2018

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

FR(1)