Genesis of Scleroderma: Role of Environmental Factors in... | NCT00213525

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

NCT00213525

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Feb 5, 2015Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Scleroderma

Interventions

Questionnary for environmental factors research

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2015

Last Update Posted Date

Feb 5, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Questionnary for environmental factors research	Other	Questionnary for environmental factors research	Healthy Controls Patients With Scleroderma

Measure	Description	Time Frame
Identification of environmental factor		Day 1

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

76 Years

Standard Ages

AdultOlder Adult

Study Population

100 Patients With Scleroderma and 300 Healthy Controls

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle MARIE, MD, PhD	University Hospital, Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rouen University Hospital		Rouen	Rouen Cedex	76031	France

Condition Browse Module

MeSH Terms

ID	Term
D045743	Scleroderma, Diffuse

Ancestor Terms

ID	Term
D012595	Scleroderma, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided