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

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ClinicalTrials.gov Identifier: NCT03543956
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Systemic Sclerosis Behavioral: Questionnaire

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.


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Study Type : Observational
Estimated Enrollment : 459 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Group/Cohort Intervention/treatment
Systemic Sclerosis patient
patients affected by SSc according to EULAR 2013 criteria
Behavioral: Questionnaire
Questionnaire




Primary Outcome Measures :
  1. 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 [ Time Frame: At baseline (day 0) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients affected by SSc according to EULAR 2013 criteria.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543956


Contacts
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Contact: Marie-Elise TRUCHETET, MD, PhD (0)5.56.79.55.56 ext +33 marie-elise.truchetet@chu-bordeaux.fr
Contact: Thomas BARNETCHE, PhD (0)5.57.82.04.93 ext +33 thomas.barnetche@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux - service de rhumatologie Recruiting
Bordeaux, France
Contact: Marie-Elise TRUCHETET, MD, PhD    (0)5.56.79.55.56 ext +33    marie-elise.truchetet@chu-bordeaux.fr   
Contact: Thomas BARNETCHE, PhD    (0)5.57.82.04.93 ext +33    thomas.barnetche@chu-bordeaux.fr   
Principal Investigator: Marie-Elise TRUCHETET, MD, PhD         
Sub-Investigator: Cyril LE-MOAL, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Marie-Elise TRUCHETET, MD, PhD CHU - Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03543956     History of Changes
Other Study ID Numbers: CHUBX 2018/09
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Silica
Organic Solvents
Toxic substances exposure

Additional relevant MeSH terms:
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Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases