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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03543956
Other study ID # CHUBX 2018/09
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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