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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
  Purpose

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
Scleroderma

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Healthy Controls

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Estimated Enrollment: 300
Study Start Date: October 2004
Estimated Study Completion Date: October 2008
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
  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213525

Contacts
Contact: Isabelle MARIE, MD, PhD (33) 2 32 88 90 03 isabelle.marie@chu-rouen.fr

Locations
France
Rouen University Hospital Recruiting
Rouen, Rouen Cedex, France, 76031
Contact: Isabelle MARIE, MD, PhD     (33) 2 32 88 90 03     isabelle.marie@chu-rouen.fr    
Principal Investigator: Isabelle MARIE, MD, PhD            
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Isabelle MARIE, MD, PhD Rouen University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00213525     History of Changes
Other Study ID Numbers: 2002/039 HP
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 16, 2013