An observational study in Scleroderma, sponsored by Istituto Giannina Gaslini. Active, not recruiting at 33 sites in 19 countries. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Istituto Giannina Gaslini · Observational
This international study adapts and validates the Localised Scleroderma Quality of Life Instrument (LoSQI) for children with JLS, a rare condition causing hardened skin and tissue.
Goals \& Methods:
Workstream 1: Translates and culturally adapts LoSQI for multi-national use, pre-testing it with patients and families.
Workstream 2: Validates the tool through a prospective study of at least 100 patients across global centers (PRINTO, CARRA, PRES).
Impact: It creates the first multi-national, disease-specific Patient-Reported Outcome (PRO) for JLS, helping researchers combine global data and embedding quality-of-life tracking into routine clinical care.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
This study's enrollment of 272 is above the median of 113 across 68 observational studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →Istituto Giannina Gaslini is the lead sponsor of 54 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
children and young people with juvenile localised scleroderma
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:
- Any co-morbidity not related to JLS or its complications which may impact on PRO.
Adaptation
Successful cross-cultural adaptation of LoSQI for use in clinical/research setting
Time frame: baseline and 4 months (+/- 2 months)
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 active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Istituto Giannina Gaslini