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

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ClinicalTrials.gov Identifier: NCT04473742
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : March 31, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473742


Contacts
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Contact: Christophe PARIS, MD, PhD 02.99.28.24.44 christophe.paris@chu-rennes.fr
Contact: Alain LESCOAT, MD alain.lescoat@chu-rennes.fr

Locations
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France
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Christophe PARIS, MD, PhD    02.99.28.24.44    christophe.paris@chu-rennes.fr   
Contact: Alain LESCOAT, MD       alain.lescoat@chu-rennes.fr   
Sub-Investigator: Valérie LECUREUR         
Sub-Investigator: Erwan DUMONTET         
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04473742    
Other Study ID Numbers: 35RC20_8878_MacFibOsis
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
efferocytosis
macrophages
silica
asbestosis
HMGB1
osteopontin
Additional relevant MeSH terms:
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Asbestosis
Autoimmune Diseases
Immune System Diseases
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases