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
  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 Intervention
Scleroderma
Other: Questionnary for environmental factors research

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Identification of environmental factor [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: October 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213525     History of Changes
Other Study ID Numbers: 2002/039/HP
Study First Received: September 13, 2005
Last Updated: February 4, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 03, 2015