Systemic Sclerosis Cohort in Seoul National University Hospital Single Center Prospective Cohort, of Patients With Systemic Sclerosis in Korea
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Internal organ involvement
Study Overview
Brief Summary
To establish a new prospective cohort of Korean patients with systemic sclerosis and track the natural history of the disease over time.
To generate new hypotheses for further investigation.
Detailed Description
Systemic sclerosis (SSc) is a multisystem and heterogeneous disease characterized by an unpredictable course and high morbidity and mortality. The complexity of SSc requires interdisciplinary diagnostic and therapeutic management and result in a growing burden for all health-care systems. For this reasons, researchers are seeking new diagnostic and therapeutic strategies to improve management of these patients. In order to improve clinical care and to develop recommendations for the diagnosis and treatment of SSc, disease registries are used to capture and track key patient information.
Therefore, SSc research associations and consortiums play a pivotal role to perform ongoing research and data collection to understanding the disease and support research projects. Currently, several national SSc registries in the UK, Germany, USA, Canada, Brazil, Australia and international registry, EUSTAR (European League Against Rheumatism scleroderma trial and research), have been established. However, the natural history of Asian populations are fully evaluated. Therefore, investigators decided to establish SSc cohort in Korean patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •SSc diagnosis according to 1980 or 2013 ACR classification criteria or 2001 criteria for the classification of early systemic sclerosis
Exclusion Criteria
- •When patients refuse to take part in the study
Outcomes
Primary Outcomes
Internal organ involvement
Time Frame: 2-year
Number of participants with internal organ involvement (Interstitial lung disease, Pulmonary arterial hypertension, Cardiac involvement, Gastrointestinal involvement, Renal involvement)
Secondary Outcomes
- Interstitial lung disease(2-year)
- Pulmonary arterial hypertension by echocardiography(2-year)
- Arrhythmia on electrocardiogram(2-year)
- University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Scale (UCLA SCTC GIT) 2.0(2-year)
- Scleroderma-Specific Health Assessment Questionnaire (SHAQ)(2-year)
- Short Form(SF)-36 Health Survey(2-year)
- Interstitial lung disease-progression(2-year)
- Pulmonary arterial hypertension by right heart catheterization (optional)(2-year)
- Interstitial lung disease-Changes of FVC% from baseline(2-year)
- Interstitial lung disease-Changes of DLCO% from baseline(2-year)
- Abnormal cardiac function without other heart disease by echocardiography(2-year)
- Pericardial effusion wihtout other heart disease by echocardiography(2-year)
Investigators
Eun Bong Lee
Principal Investigator
Seoul National University Hospital