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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213525
First Posted: September 21, 2005
Last Update Posted: February 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
September 13, 2005
September 21, 2005
February 5, 2015
October 2004
October 2008   (Final data collection date for primary outcome measure)
Identification of environmental factor [ Time Frame: Day 1 ]
Not Provided
Complete list of historical versions of study NCT00213525 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Controls
Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Healthy Controls

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.

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
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
100 Patients With Scleroderma and 300 Healthy Controls
Scleroderma
Other: Questionnary for environmental factors research
Questionnary for environmental factors research
  • Patients With Scleroderma
    Assessments of questionnary for environmental factors research
    Intervention: Other: Questionnary for environmental factors research
  • Healthy Controls
    Assessments of questionnary for environmental factors research
    Intervention: Other: Questionnary for environmental factors research
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
October 2008
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 76 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00213525
2002/039/HP
No
Not Provided
Not Provided
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Isabelle MARIE, MD, PhD Rouen University Hospital
University Hospital, Rouen
February 2015