Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Controls

Completed

• Conditions: Scleroderma

• Registration Number: NCT00213525
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental factors, and particularly toxic drug exposure, in the genesis of scleroderma has been suggested.

This prompted us to conduct this prospective, case-control, multicentric study, including 2 groups of subjects:

* 100 patients with scleroderma

* 300 sex- and age-matched healthy controls. The aim of our study is to determine whether exposure to toxics is higher in patients with scleroderma compared with healthy controls.

Detailed Description

The data of patients with scleroderma and healthy controls will be compared regarding:

* a standardized questionnaire about "cursus laboris" at initial inclusion

* a search for toxics in blood, urine and hair: at initial exvaluation, 6 month and 2 year-follow-up

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• patients with scleroderma with:

  • age range : 18 to 76 years
  • written consent

Exclusion Criteria

• patients with other connective-tissue disorders
• pregnant women
• patients with psychiatric conditions
• unwritten consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of environmental factor	Day 1

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, Rouen Cedex, France