Calcinosis in a Single-Center Scleroderma Population (SSc-calcinosis)
This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how common and if there are any risk factors for having calcinosis
2) to identify common complications associated with scleroderma-related calcinosis.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||10 Years|
|Official Title:||A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders|
- risk factors and outcomes in scleroderma calcinosis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
This is an observational study of scleroderma calcinosis over 3 years duration, to assess possible risk factors (including serologic studies and disease types) as well as common complications that occur in those with scleroderma calcinosis in this time period.
No additional intervention will be delivered, other than standard of care for this complication.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2030|
|Estimated Primary Completion Date:||October 2022 (Final data collection date for primary outcome measure)|
This is a prospective study of scleroderma- spectrum patients focused on soft tissue calcinosis in order 1) to better understand the risk factors (including clinical/laboratory characteristics, and serology) of calcinosis in the scleroderma-spectrum disorders (limited or diffuse systemic sclerosis with or without overlap of inflammatory arthritis and/or myositis).
2) view common complications associated with calcinosis.
Better understanding of scleroderma calcinosis would lead to other studies that eventually will define better treatment options for this incurable and often disabling complication.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02062125
|Contact: Vivien Hsu, MDfirstname.lastname@example.org|
|Contact: Deborah McCloskey, RN||732-418-8484|
|United States, New Jersey|
|RWJ Medical School||Recruiting|
|New Brunswick, New Jersey, United States, 08903|