Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition

NCT ID: NCT03543956

Last Updated: 2019-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-04

Study Completion Date

2019-06-27

Brief Summary

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Systemic Sclerosis (SSc) is an inflammatory chronic disease that can lead to structural damage and handicap. The SSc physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the SSc mechanism, and improves the diagnosis and the treatment of the disease.

Detailed Description

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Studies show that the risk associated with high cumulative exposure to silica and organic solvents appears to be strongly increased in SSc. Moreover, exposure to silica is associated with a specific type of SSc phenotype with a worse prognosis. However, the type, intensity and probability of these expositions are unknown.

The aim of the study is to precisely determine type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix.

Conditions

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Systemic Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Systemic Sclerosis patient

patients affected by SSc according to EULAR 2013 criteria

Questionnaire

Intervention Type BEHAVIORAL

Questionnaire

Interventions

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Questionnaire

Questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients aged over 18 years old
* Speaking and understanding French language
* Being informed about the study and having given his consent
* Affected by SSc according to EULAR 2013 criteria

Exclusion Criteria

* Patient under tutorship
* Patient who refuse to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Elise TRUCHETET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux - service de rhumatologie

Bordeaux, , France

Site Status

Countries

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France

References

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Galli G, De Pous-Gerardin C, Hanguehard R, Berthy F, Le Moal C, Lourde C, Barnetche T, Skopinski S, Contin-Bordes C, Delva F, Carles C, Truchetet ME. Occupational quantitative exposure to crystalline silica, solvents and pesticides and risk of clinical forms of systemic sclerosis. Rheumatology (Oxford). 2024 Dec 1;63(12):3397-3406. doi: 10.1093/rheumatology/kead602.

Reference Type DERIVED
PMID: 37963059 (View on PubMed)

Other Identifiers

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CHUBX 2018/09

Identifier Type: -

Identifier Source: org_study_id

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