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

Completed

• Conditions: Systemic Sclerosis

• Registration Number: NCT03543956
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-06-01
• Study Start: 2018-06-04
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-27
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analyse 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	At baseline (day 0)

Trial Locations

Locations (1)

CHU de Bordeaux - service de rhumatologie; 🇫🇷 Bordeaux, France