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

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04473742

Collaborator

(none)

Enrollment

Location

Arms

8.5

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
History of Exposure to Silica or Asbestosis Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases	Biological: Blood collection Biological: Blood sample Biological: Blood sample	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 31, 2021

Actual Primary Completion Date :

Dec 15, 2021

Actual Study Completion Date :

Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients exposed to silica	Biological: Blood collection 4 EDTA tubes for 24 mL blood collection Biological: Blood sample 1 drying tube for 6 mL blood collection
Active Comparator: Patients exposed to asbestos fibres	Biological: Blood collection 4 EDTA tubes for 24 mL blood collection Biological: Blood sample 2 drying tubes for 12 mL blood collection

Arm

Intervention/Treatment

Experimental: Patients exposed to silica

Biological: Blood collection

4 EDTA tubes for 24 mL blood collection

Biological: Blood sample

1 drying tube for 6 mL blood collection

Active Comparator: Patients exposed to asbestos fibres

Biological: Blood collection

4 EDTA tubes for 24 mL blood collection

Biological: Blood sample

2 drying tubes for 12 mL blood collection

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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