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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213525
First received: September 13, 2005
Last updated: February 4, 2015
Last verified: February 2015

September 13, 2005
February 4, 2015
October 2004
October 2008   (final data collection date for primary outcome measure)
Identification of environmental factor [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00213525 on ClinicalTrials.gov Archive Site
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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
Time Perspective: Prospective
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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
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*   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
Both
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
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University Hospital, Rouen
University Hospital, Rouen
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Principal Investigator: Isabelle MARIE, MD, PhD Rouen University Hospital
University Hospital, Rouen
February 2015

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