Back to resultsEffects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages (MacFibOsis)
Primary Purpose
History of Exposure to Silica or Asbestosis, Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood collection
Blood sample
Blood sample
Sponsored by
About this trial
This is an interventional other trial for History of Exposure to Silica or Asbestosis focused on measuring efferocytosis, macrophages, silica, asbestosis, HMGB1, osteopontin
Eligibility Criteria
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
Sites / Locations
- CHU de Rennes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients exposed to silica
Patients exposed to asbestos fibres
Arm Description
Outcomes
Primary Outcome Measures
Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM
Secondary Outcome Measures
EI calculation in patients positive for ANA vs patients negative for ANA
Serum concentration of HMGB1 and Osteopontin (SPP1) by ELISA
Full Information
NCT ID
NCT04473742
First Posted
July 13, 2020
Last Updated
January 3, 2022
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04473742
Brief Title
Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages
Acronym
MacFibOsis
Official Title
Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients exposed to silica
Arm Type
Experimental
Arm Title
Patients exposed to asbestos fibres
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Blood collection
Intervention Description
4 EDTA tubes for 24 mL blood collection
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
2 drying tubes for 12 mL blood collection
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
1 drying tube for 6 mL blood collection
Primary Outcome Measure Information:
Title
Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
EI calculation in patients positive for ANA vs patients negative for ANA
Time Frame
Through study completion, an average of 2 years
Title
Serum concentration of HMGB1 and Osteopontin (SPP1) by ELISA
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages
We'll reach out to this number within 24 hrs