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

Systemic Sclerosis Clinical Trial

— VISSEXPOSITION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543956
• Other study ID #: CHUBX 2018/09
• Status: Completed
• Start date: June 4, 2018
• Est. completion date: June 27, 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Behavioral:
• Questionnaire
Questionnaire

Locations

Country	Name	City	State
France	CHU de Bordeaux - service de rhumatologie	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)