An observational study in Scleroderma, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
Systemic sclerosis is a disease characterized by the development of fibrotic lesions in the skin and deep internal organs such as the lungs, heart, and gastrointestinal tract, as well as vascular manifestations such as Raynaud's phenomenon, and, more rarely, pulp ischemia, pulmonary arterial hypertension (PAH), or renal crisis.
Eligible patients are the 250 patients with SSc. They will receive by mail an information sheet/patient consent form (in duplicate) along with an explanatory letter and the M0 and M3 questionnaires for their review. They will then be contacted by phone to answer any questions they may have (particularly regarding the study's objectives and procedures). If they agree to participate, they will be asked to complete and sign both copies of the consent form, complete the "M0" questionnaires, and return one copy of the signed consent form and the "M0" questionnaires by mail using the pre-addressed envelope provided for this purpose or in person. Patients will then return the completed self-administered questionnaires to M3 by mail (or by email or in person, depending on the patient's preference).
More recently, new disability and patient assessment questionnaires have been introduced internationally: the ScleroID (Becker MO 2022) and the SSPRO (Man A et al. 2017). While these questionnaires are recognized as useful for ScleroID internationally, their development did not include validation in French within a French population. In fact, these questionnaires have not been translated into French and therefore cannot be used without French-language validation.
534 studies on the registry are indexed under Scleroderma, Diffuse; 115 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 140 observational studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of French-speaking patients with systemic sclerosis who meet the 2013 ACR/EULAR classification criteria.
The objective of this study is to validate French-language disability questionnaires for this patient population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient
Other: Questionnaires
French-language questionnaires assessing disability, quality of life, and disease status.
CSF 17 (Cochin 17-item Scleroderma Functional scale)
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.
Time frame: Day 0
CSF 17 (Cochin 17-item Scleroderma Functional scale)
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.
Time frame: Month 3
ScleroID questionnaire
Disability questionnaire, a scale requiring validation designed to assess global functional impairment associated with SSc
Time frame: Day 0
ScleroID questionnaire
Disability questionnaire, a scale requiring validation designed to assess global functional impairment associated with SSc
Time frame: Month 3
SSPRO
Patient-reported assessment questionnaire; scale requiring validation, assessing the patient's evaluation of their disease.
Time frame: Day 0
SSPRO
Patient-reported assessment questionnaire; scale requiring validation, assessing the patient's evaluation of their disease.
Time frame: Month 3
HAQ-DI questionnaire
Scales for measuring functional disability in SSc
Time frame: Day 0
HAQ-DI questionnaire
Scales for measuring functional disability in SSc
Time frame: Month 3
SHAQ questionnaire
Scales for measuring functional disability in SSc
Time frame: Day 0
SHAQ questionnaire
Scales for measuring functional disability in SSc
Time frame: Month 3
PROMIS-29 questionnaire
Questions regarding patient-perceived health.
Time frame: Day 0
PROMIS-29 questionnaire
Questions regarding patient-perceived health.
Time frame: Month 3
SF-12 questionnaire
Questions regarding patient-perceived health.
Time frame: Day 0
SF-12 questionnaire
Questions regarding patient-perceived health.
Time frame: Month 3
Anchoring questionnaire
Anchoring questionnaire
Time frame: Day 0
Anchoring questionnaire
Anchoring questionnaire
Time frame: Month 3
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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