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

January 3, 2022 updated by: Rennes University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • CHU de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients exposed to silica
Biological: Blood collection
4 EDTA tubes for 24 mL blood collection
Biological: Blood sample
2 drying tubes for 12 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
Biological: Blood sample
1 drying tube for 6 mL blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
EI calculation in patients positive for ANA vs patients negative for ANA
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Serum concentration of HMGB1 and Osteopontin (SPP1) by ELISA
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 31, 2021

Primary Completion (ACTUAL)

December 15, 2021

Study Completion (ACTUAL)

December 15, 2021

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (ACTUAL)

July 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC20_8878_MacFibOsis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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