NCT04473742

Brief Summary

Evaluation of the efferocytosis capacities of blood Monocyte Derived Macrophages (MDM) from patients with a history of asbestosis or silica exposure and comparison of these capacities with those of MDM from healthy donors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

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

July 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

July 13, 2020

Last Update Submit

January 3, 2022

Conditions

History of Exposure to Silica or AsbestosisPositive Testing for ANA as a Marker of Systemic Autoimmune Diseases

Keywords

efferocytosismacrophagessilicaasbestosisHMGB1osteopontin

Outcome Measures

Primary Outcomes (1)

  • Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM

    Through study completion, an average of 2 years

Secondary Outcomes (2)

  • EI calculation in patients positive for ANA vs patients negative for ANA

    Through study completion, an average of 2 years

  • Serum concentration of HMGB1 and Osteopontin (SPP1) by ELISA

    Through study completion, an average of 2 years

Study Arms (2)

Patients exposed to silica

EXPERIMENTAL
Biological: Blood collectionBiological: Blood sample

Patients exposed to asbestos fibres

ACTIVE COMPARATOR
Biological: Blood collectionBiological: Blood sample

Interventions

Blood collectionBIOLOGICAL

4 EDTA tubes for 24 mL blood collection

Patients exposed to asbestos fibresPatients exposed to silica
Blood sampleBIOLOGICAL

2 drying tubes for 12 mL blood collection

Patients exposed to asbestos fibres

Eligibility Criteria

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

You may qualify if:

  • Patient older than 18 Yo
  • Addressed to the department of occupational disease
  • With a history of asbestosis or silica exposure evaluated by a dedicated questionnaire and a throughout examination of the history of occupations, according to standard procedures for the follow-up of at risk workers.
  • Persons who received an oral and written information on the protocol and signed the informed consent form

You may not qualify if:

  • Pregnant or breastfeeding women
  • Subject legally protected (under judicial protection, guardianship), persons deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Asbestosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

PneumoconiosisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung InjuryOccupational Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 16, 2020

Study Start

March 31, 2021

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)