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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital, Rouen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213525
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 13, 2005
September 13, 2005
October 2004
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No Changes Posted
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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
Primary Purpose: Screening
Time Perspective: Longitudinal
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Scleroderma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
October 2008
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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
Both
18 Years to 76 Years
Yes
Contact: Isabelle MARIE, MD, PhD (33) 2 32 88 90 03 isabelle.marie@chu-rouen.fr
France
 
NCT00213525
2002/039 HP
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University Hospital, Rouen
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Principal Investigator: Isabelle MARIE, MD, PhD Rouen University Hospital
University Hospital, Rouen
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP