NCT03543956

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

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

First Submitted

Initial submission to the registry

May 18, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

June 4, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

May 18, 2018

Last Update Submit

September 10, 2019

Conditions

Keywords

SilicaOrganic SolventsToxic substances exposure

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Systemic Sclerosis patient

patients affected by SSc according to EULAR 2013 criteria

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaire

Systemic Sclerosis patient

Eligibility Criteria

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

Patients affected by SSc according to EULAR 2013 criteria.

You may qualify if:

  • 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

You may not qualify if:

  • Patient under tutorship
  • Patient who refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Marie-Elise TRUCHETET, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 18, 2018

First Posted

June 1, 2018

Study Start

June 4, 2018

Primary Completion

June 27, 2019

Study Completion

June 27, 2019

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations