Validation of the UCLA Scleroderma Clinical Trial Gastrointestinal Tract Instrument Version 2.0 for Juvenile Systemic Sclerosis
Validation of UCLA GIT for jSSC
What is the goal of the study?
The aim of this prospective multicenter study is to validate the UCLA Scleroderma Clinical Trial Gastrointestinal Tract Instrument Version 2.0 (UCLA SCT GIT 2.0) for pediatric use as a reliable measure of gastrointestinal tract disease (GI) disease in juvenile systemic scleroderma (jSSc). This will be a prospective multicenter study to validate a pediatric-specific questionnaire for GI disease in jSSc for future application in clinical and research trials. JSSc is a rare connective tissue disease of childhood with an estimated incidence of less than 1 per million children per year. Currently there are no validated pediatric questionnaires to assess the extent of GI disease in jSSc. The UCLA SCT GIT 2.0 questionnaire is validated and widely used in adult patients with systemic sclerosis (SSc). We plan to test this instrument for validation in jSSc using the OMERACT (Outcome Measures in Rheumatology) criteria of feasibility, truth, and discrimination validity.
Who can participate in the study?
Please contact the study team listed below to learn more.