Effects of Silica and Asbestos Fibres on the Efferocytosi... | NCT04473742

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

NCT04473742

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Jan 4, 2022Actual

Enrollment

23Actual

Phase

Not Applicable

Conditions

History of Exposure to Silica or Asbestosis
Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases

Interventions

Blood collection
Blood sample
Blood sample

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2021Actual

Primary Completion Date

Dec 15, 2021Actual

Completion Date

Dec 15, 2021Actual

First Submitted Date

Jul 13, 2020

First Submission Date that Met QC Criteria

Jul 13, 2020

First Posted Date

Jul 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2022

Last Update Posted Date

Jan 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients exposed to silica	Experimental		Biological: Blood collection Biological: Blood sample
Patients exposed to asbestos fibres	Active Comparator		Biological: Blood collection Biological: Blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood collection	Biological	4 EDTA tubes for 24 mL blood collection	Patients exposed to asbestos fibres Patients exposed to silica

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Rennes		Rennes		35033	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001195	Asbestosis

Ancestor Terms

ID	Term
D011009	Pneumoconiosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided