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Completed

NCT Number: NCT04473742

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

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.

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Key information

Conditions

History of Exposure to Silica or Asbestosis Asbestosis Lung Diseases Lung Diseases, Interstitial Lung Injury Occupational Diseases Pneumoconiosis Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection

Biological

4 EDTA tubes for 24 mL blood collection

Blood sample

Biological

2 drying tubes for 12 mL blood collection

Primary outcomes

  1. 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 outcomes

  1. EI calculation in patients positive for ANA vs patients negative for ANA

    Time frame: Through study completion, an average of 2 years

  2. Serum concentration of HMGB1 and Osteopontin (SPP1) by ELISA

    Time frame: Through study completion, an average of 2 years

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: MacFibOsis

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2020
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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