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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by University Hospital, Rouen.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT00213525

First received: September 13, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

October 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Scleroderma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

300

Completion Date

October 2008

Primary Completion Date

Not Provided

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 Number ^ICMJE

NCT00213525

Other Study ID Numbers ^ICMJE

2002/039 HP

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital, Rouen

Collaborators ^ICMJE

Not Provided

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

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