NCT00213525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

4 years

First QC Date

September 13, 2005

Last Update Submit

February 4, 2015

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (1)

  • Identification of environmental factor

    Day 1

Study Arms (2)

Patients With Scleroderma

Assessments of questionnary for environmental factors research

Other: Questionnary for environmental factors research

Healthy Controls

Assessments of questionnary for environmental factors research

Other: Questionnary for environmental factors research

Interventions

Questionnary for environmental factors researchOTHER

Questionnary for environmental factors research

Healthy ControlsPatients With Scleroderma

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 Patients With Scleroderma and 300 Healthy Controls

You may qualify if:

  • patients with scleroderma with:
  • age range : 18 to 76 years
  • written consent

You may not qualify if:

  • patients with other connective-tissue disorders
  • pregnant women
  • patients with psychiatric conditions
  • unwritten consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, Rouen Cedex, 76031, France

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Isabelle MARIE, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 2004

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

FR(1)