Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04473742

Acronym

MacFibOsis

Enrollment

Registered

2020-07-16

Start date

2021-03-31

Completion date

2021-12-15

Last updated

2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

History of Exposure to Silica or Asbestosis, Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases

Keywords

efferocytosis, macrophages, silica, asbestosis, HMGB1, osteopontin

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.

Detailed description

Patients with a proven history or current exposure will have 4 EDTA tubes drawn, approximately 24mL of fresh whole blood for efferocytosis assessment and : * 2 x 6mL serum tubes for the assessment of Antinuclear Antibody (ANA) positivity, serum high-mobility group box 1 (HMGB1) and osteopontin for patients exposed to asbestos * 1 x 6mL serum tube for serum HMGB1 and osteopontin for patients exposed to silica

Interventions

BIOLOGICALBlood collection

4 EDTA tubes for 24 mL blood collection

BIOLOGICALBlood sample

2 drying tubes for 12 mL blood collection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM	Through study completion, an average of 2 years

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026