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

NCT ID: NCT04473742

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2021-12-15

Brief Summary

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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

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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

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients exposed to silica

Group Type EXPERIMENTAL

Blood collection

Intervention Type BIOLOGICAL

4 EDTA tubes for 24 mL blood collection

Blood sample

Intervention Type BIOLOGICAL

1 drying tube for 6 mL blood collection

Patients exposed to asbestos fibres

Group Type ACTIVE_COMPARATOR

Blood collection

Intervention Type BIOLOGICAL

4 EDTA tubes for 24 mL blood collection

Blood sample

Intervention Type BIOLOGICAL

2 drying tubes for 12 mL blood collection

Interventions

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Blood collection

4 EDTA tubes for 24 mL blood collection

Intervention Type BIOLOGICAL

Blood sample

2 drying tubes for 12 mL blood collection

Intervention Type BIOLOGICAL

Blood sample

1 drying tube for 6 mL blood collection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Rennes

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC20_8878_MacFibOsis

Identifier Type: -

Identifier Source: org_study_id

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