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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00213525
Enrollment
300
Registered
2005-09-21
Start date
2004-10-31
Completion date
2008-10-31
Last updated
2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma

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.

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

Interventions

OTHERQuestionnary for environmental factors research

Questionnary for environmental factors research

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Identification of environmental factorDay 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026