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

NCT ID: NCT00213525

Last Updated: 2015-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-10-31

Brief Summary

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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

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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

Conditions

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Scleroderma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients With Scleroderma

Assessments of questionnary for environmental factors research

Questionnary for environmental factors research

Intervention Type OTHER

Questionnary for environmental factors research

Healthy Controls

Assessments of questionnary for environmental factors research

Questionnary for environmental factors research

Intervention Type OTHER

Questionnary for environmental factors research

Interventions

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Questionnary for environmental factors research

Questionnary for environmental factors research

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle MARIE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Rouen University Hospital

Rouen, Rouen Cedex, France

Site Status

Countries

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France

Other Identifiers

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2002/039/HP

Identifier Type: -

Identifier Source: org_study_id

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