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

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ClinicalTrials.gov Identifier: NCT00213525
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Scleroderma Other: Questionnary for environmental factors research

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 Design

Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Healthy Controls
Study Start Date : October 2004
Primary Completion Date : October 2008
Study Completion Date : October 2008


Groups and Cohorts

Group/Cohort Intervention/treatment
Patients With Scleroderma
Assessments of questionnary for environmental factors research
Other: Questionnary for environmental factors research
Questionnary for environmental factors research
Healthy Controls
Assessments of questionnary for environmental factors research
Other: Questionnary for environmental factors research
Questionnary for environmental factors research


Outcome Measures

Primary Outcome Measures :
  1. Identification of environmental factor [ Time Frame: Day 1 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
100 Patients With Scleroderma and 300 Healthy Controls
Criteria

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
Contacts and Locations

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): NCT00213525


Locations
France
Rouen University Hospital
Rouen, Rouen Cedex, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Isabelle MARIE, MD, PhD Rouen University Hospital
More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213525     History of Changes
Other Study ID Numbers: 2002/039/HP
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases