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

University Hospital, Rouen

Status: Completed

Conditions: Scleroderma

Treatments: Other: Questionnary for environmental factors research

Study type: Observational

Funder types: Other

Identifiers

NCT00213525

2002/039/HP

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Patients With Scleroderma

Description:

Assessments of questionnary for environmental factors research

Treatment:

Other: Questionnary for environmental factors research

Healthy Controls

Description:

Assessments of questionnary for environmental factors research

Treatment:

Other: Questionnary for environmental factors research