Ireland
--:--IST
Starting soon Observational

A Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status.

NCT07888842 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-11
Last updated
2026-10-22

Condition(s) studied

Scleroderma

Investigational drug(s) / intervention(s)

Questionnaires

Questionnaires: French-language questionnaires assessing disability, quality of life, and disease status.

Study summary

The main objective of this study is to validate, in French, new questionnaires assessing disability, quality of life, and patient-reported outcomes in systemic sclerosis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged 18 years or older with SSc who meet the 2013 ACR/EULAR criteria (Van Hoogen et al., ARD 2013). * Patients with a good understanding of the French language. * Who have provided informed consent to participate in the study Exclusion Criteria: * Patients with associated chronic disabling conditions: stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, amputees, etc. * Patients with cognitive impairments * Patients with difficulties understanding or speaking French * Adults under legal guardianship

Primary outcome measure(s)

  • CSF 17 (Cochin 17-item Scleroderma Functional scale) — Day 0
    Questionnaire developed by the internal medicine department's research group for the SCISCIF studies to assess the patient's self-perceived health. The aim of this study is to validate French-language disability questionnaires for this patient population.
  • CSF 17 (Cochin 17-item Scleroderma Functional scale) — Month 3
    Questionnaire developed by the internal medicine department's research group for the SCISCIF studies to assess the patient's self-perceived health. The aim of this study is to validate French-language disability questionnaires for this patient population.
  • ScleroID questionnaire — Day 0
    Disability questionnaire, a scale requiring validation designed to assess global functional impairment associated with SSc
  • ScleroID questionnaire — Month 3
    Disability questionnaire, a scale requiring validation designed to assess global functional impairment associated with SSc
  • SSPRO — Day 0
    Patient-reported assessment questionnaire; scale requiring validation, assessing the patient's evaluation of their disease.
  • SSPRO — Month 3
    Patient-reported assessment questionnaire; scale requiring validation, assessing the patient's evaluation of their disease.
  • HAQ-DI questionnaire — Day 0
    Scales for measuring functional disability in SSc
  • HAQ-DI questionnaire — Month 3
    Scales for measuring functional disability in SSc
  • SHAQ questionnaire — Day 0
    Scales for measuring functional disability in SSc
  • SHAQ questionnaire — Month 3
    Scales for measuring functional disability in SSc
  • PROMIS-29 questionnaire — Day 0
    Questions regarding patient-perceived health.
  • PROMIS-29 questionnaire — Month 3
    Questions regarding patient-perceived health.
  • SF-12 questionnaire — Day 0
    Questions regarding patient-perceived health.
  • SF-12 questionnaire — Month 3
    Questions regarding patient-perceived health.
  • Anchoring questionnaire — Day 0
    Anchoring questionnaire
  • Anchoring questionnaire — Month 3
    Anchoring questionnaire

Trial sites (1)

FacilityCityRegionStatus
Department of Internal Medicine - Cochin hospital Paris IDF
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07888842 on ClinicalTrials.gov ↗ ← All trials in France