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

History of Exposure to Silica or Asbestosis Clinical Trial

— MacFibOsis  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473742
• Other study ID #: 35RC20_8878_MacFibOsis
• Status: Completed
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: January 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• Blood collection
4 EDTA tubes for 24 mL blood collection
• Blood sample
2 drying tubes for 12 mL blood collection
• Blood sample
1 drying tube for 6 mL blood collection

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM		Through study completion, an average of 2 years
Secondary	EI calculation in patients positive for ANA vs patients negative for ANA		Through study completion, an average of 2 years
Secondary	Serum concentration of HMGB1 and Osteopontin (SPP1) by ELISA		Through study completion, an average of 2 years