Professional and Personal Toxic Exposure in Systemic Scle... | NCT03543956

Studies
Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition

NCT03543956

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

Sep 11, 2019Actual

Enrollment

226Actual

Phase

Not provided

Conditions

Systemic Sclerosis

Interventions

Questionnaire

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

Sep 2019

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

Jun 4, 2018Actual

Primary Completion Date

Jun 27, 2019Actual

Completion Date

Jun 27, 2019Actual

First Submitted Date

May 18, 2018

First Submission Date that Met QC Criteria

May 18, 2018

First Posted Date

Jun 1, 2018Actual

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

Sep 10, 2019

Last Update Posted Date

Sep 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Systemic Sclerosis (SSc) is an inflammatory chronic disease that can lead to structural damage and handicap. The SSc physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the SSc mechanism, and improves the diagnosis and the treatment of the disease.

Detailed Description

Studies show that the risk associated with high cumulative exposure to silica and organic solvents appears to be strongly increased in SSc. Moreover, exposure to silica is associated with a specific type of SSc phenotype with a worse prognosis. However, the type, intensity and probability of these expositions are unknown.

The aim of the study is to precisely determine type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

226Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Systemic Sclerosis patient		patients affected by SSc according to EULAR 2013 criteria	Behavioral: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Behavioral	Questionnaire	Systemic Sclerosis patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analyse type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix		At baseline (day 0)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged over 18 years old
Speaking and understanding French language
Being informed about the study and having given his consent
Affected by SSc according to EULAR 2013 criteria

Exclusion Criteria:

Patient under tutorship
Patient who refuse to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients affected by SSc according to EULAR 2013 criteria.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Elise TRUCHETET, MD, PhD	University Hospital, Bordeaux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Bordeaux - service de rhumatologie		Bordeaux			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37963059	Derived	Galli G, De Pous-Gerardin C, Hanguehard R, Berthy F, Le Moal C, Lourde C, Barnetche T, Skopinski S, Contin-Bordes C, Delva F, Carles C, Truchetet ME. Occupational quantitative exposure to crystalline silica, solvents and pesticides and risk of clinical forms of systemic sclerosis. Rheumatology (Oxford). 2024 Dec 1;63(12):3397-3406. doi: 10.1093/rheumatology/kead602.

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms