Institutional Review Board, Hospital for Special Surgery
October 06, 2016
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Robert F. Spiera, MD
Horatio Wildman, MD
Systemic sclerosis is an autoimmune condition with an unknown cause. Diffuse cutaneous Systemic Sclerosis (DcSSc) is the most severe subtype of this disease and treatment options are emphasized for patients in the early stages of DcSSc. Yet there are many questions about the natural history of disease in people with DcSSc. The PRESS study is a natural history study that collects data and biological material such as optional blood samples and tissue biopsies. This study is being done to try to find out the causes of scleroderma and how baseline tests (such as radiographs, clinical examination, quality of life questionnaires) predict future outcome. This multi-center registry is open to enrollment. The enrollment period is ongoing, as is the duration of follow-up. Follow up visits occur every 6 months. ECHO, PFT, HRCT test are performed yearly as part of clinical care. Currently there are 26 patients enrolled in the registry at the Hospital for Special Surgery.