History of Exposure to Silica or AsbestosisMacFibOsisNCT04473742

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

A study testing Blood collection and Blood sample in people with History of Exposure to Silica or Asbestosis and Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases, run by Rennes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: History of Exposure to Silica or Asbestosis, Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases
What is being tested?: Blood collection and Blood sample
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteFrance
Study dates: 31 Mar 2021to 15 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Pregnant or breastfeeding women
Subject legally protected (under judicial protection, guardianship), persons deprived of liberty

Trial locations and contacts

1 site in 1 country.

France1 site

CHU de Rennes
Rennes, 35033

Other trials in France

About this study

Read the 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

Conditions: History of Exposure to Silica or Asbestosis, Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases
Being tested: Blood collection, Blood sample
Keywords: efferocytosis, macrophages, silica, asbestosis, HMGB1, osteopontin
Medical subject headings: Asbestosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood collectionBiological
4 EDTA tubes for 24 mL blood collection
Blood sampleBiological
2 drying tubes for 12 mL blood collection
Blood sampleBiological
1 drying tube for 6 mL blood collection

Study groups in NCT04473742
Study group	Role	What they receive
Patients exposed to silica	Experimental	Not described Receives: Biological: Blood collection; Biological: Blood sample
Patients exposed to asbestos fibres	Active comparator	Not described Receives: Biological: Blood collection; Biological: Blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM
Measured: Through study completion, an average of 2 years

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 202115 Dec 2021

First posted16 Jul 2020
Study start31 Mar 2021
Primary completion15 Dec 2021
Study completion15 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for History of Exposure to Silica or AsbestosisStudies of the same condition, open and under way.
More trials run by Rennes University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04473742
Sponsor's protocol ID: 35RC20_8878_MacFibOsis
Acronym: MacFibOsis
Status last verified: Jan 2022
First submitted: 13 Jul 2020
Last updated: 4 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages
ClinicalTrials.gov ID: NCT04473742
Acronym / sponsor ID: MacFibOsis / 35RC20_8878_MacFibOsis
Conditions: 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
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Rennes University HospitalUniversity, hospital or other
Study start: 31 Mar 2021 (actual)
Primary completion: 15 Dec 2021 (actual)
Study completion: 15 Dec 2021 (actual)
First posted: 16 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Patients exposed to silica	Experimental	Biological: Blood collection, Biological: Blood sample
Patients exposed to asbestos fibres	Active comparator	Biological: Blood collection, Biological: Blood sample

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

Pregnant or breastfeeding women
Subject legally protected (under judicial protection, guardianship), persons deprived of liberty

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood collection4 EDTA tubes for 24 mL blood collection	Biological	Patients exposed to asbestos fibres, Patients exposed to silica
Blood sample2 drying tubes for 12 mL blood collection	Biological	Patients exposed to asbestos fibres
Blood sample1 drying tube for 6 mL blood collection	Biological	Patients exposed to silica

Primary outcome

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

2 secondary outcomes

EI calculation in patients positive for ANA vs patients negative for ANA
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04473742.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.