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

Scleroderma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213525
• Other study ID #: 2002/039/HP
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: February 4, 2015
• Start date: October 2004
• Est. completion date: October 2008

Study information

• Verified date: February 2015
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Other:
• Questionnary for environmental factors research
Questionnary for environmental factors research

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen	Rouen Cedex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of environmental factor		Day 1	No