Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213525
Status:
COMPLETED
Last Update Posted:
2015-02-05
First Post:
2005-09-13
Brief Title:
Genesis of Scleroderma Role of Environmental Factors in 100 Patients With Scleroderma and 300 Controls
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Genesis of Scleroderma Role of Environmental Factors in 100 Patients With Scleroderma and 300 Healthy Controls
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None