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

This study is currently recruiting participants.

Verified by University Hospital, Rouen, September 2005

First Received: September 13, 2005 No Changes Posted

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00213525

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

U.S. FDA Resources

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

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 Cedex
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

Study ID Numbers:	2002/039 HP
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00213525 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Skin Diseases
Connective Tissue Diseases
Scleroderma
Healthy
Scleroderma, Localized

Additional relevant MeSH terms:

Skin Diseases
Connective Tissue Diseases
Scleroderma, Localized

ClinicalTrials.gov processed this record on May 07, 2009