The goal of this study is to develop an early systemic sclerosis (SSc) registry in the United States (US). A registry is a group of patients that are observed over time. This is a non-interventional study, meaning that they are no study specific medications to take or procedures to undergo. The specific aims include ongoing assessment of the natural history of early SSc patients by capturing and analyzing clinical data, patient reported outcomes, and laboratory data. This is a multi-center study with sites spread across the U.S. This study is funded by the Scleroderma Research Foundation.

The PRESS study is a natural history study which will collect data and biological material. All patients who participate will need to contribute clinical data (Part 1). Additionally, three optional sample collection protocols will also be followed: Part 2: blood samples for protein, DNA and RNA studies; Part 3: Skin biopsy samples; Part 4: Other tissue biopsies (e.g. gastrointestinal biopsy) or bronchoalveolar lavage (BAL) from patients who have undergone the respective procedures as part of their routine clinical care.