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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening, Longitudinal, Case Control, Prospective Study

Condition ^ICMJE

Scleroderma

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

300

Completion Date

October 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 76 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Isabelle MARIE, MD, PhD

(33) 2 32 88 90 03

isabelle.marie@chu-rouen.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00213525

Responsible Party

Study ID Numbers ^ICMJE

2002/039 HP

Study Sponsor ^ICMJE

University Hospital, Rouen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Isabelle MARIE, MD, PhD

Rouen University Hospital

Information Provided By

University Hospital, Rouen

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP