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PRESSY: Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03262922
Collaborator
(none)
327
Enrollment
1
Location
66.7
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to compare the exposure to environmental and professional toxics by patients with systemic scleroderma and by patients not achieved by this pathology.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study is based on a questionnaire.

    The data will be collected according a retrospective and prospective design :

    • at diagnostic of the disease

    • at the inclusion in the systemic scleroderma cohort

    • during the annual visit (in 2017-2018-2019-2020)

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    327 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment
    Actual Study Start Date :
    Jul 29, 2016
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Feb 18, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Questionnaire to evaluate the exposition of environmental and professional toxics [once a year up to 2020]

      clinical, personal and professional data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with systemic scleroderma
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Rennes Rennes France

    Sponsors and Collaborators

    • Rennes University Hospital

    Investigators

    • Principal Investigator: Patrick JEGO, Pr, Rennes University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rennes University Hospital
    ClinicalTrials.gov Identifier:
    NCT03262922
    Other Study ID Numbers:
    • 35RC16_3032_PRESSY
    First Posted:
    Aug 25, 2017
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rennes University Hospital
    systemic scleroderma
    environmental and professional toxics
    Additional relevant MeSH terms:
    Scleroderma, Systemic
    Scleroderma, Diffuse
    Scleroderma, Localized

    Study Results

    No Results Posted as of Apr 4, 2022