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

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.

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Key information

Conditions

Scleroderma Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rouen University Hospital

Rouen, Rouen Cedex, 76031, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnary for environmental factors research

Other

Questionnary for environmental factors research

Primary outcomes

Identification of environmental factor

Time frame: Day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Sep 21, 2005
Registry last updated: Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed