Clinical trial NCT02819947: Seoul National University Hospital Systemic Sclerosis Cohort
Official title: Systemic Sclerosis Cohort in Seoul National University Hospital Single Center Prospective Cohort, of Patients With Systemic Sclerosis in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis
cohort
Korean
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SSc diagnosis according to 1980 or 2013 ACR classification criteria or 2001 criteria for the classification of early systemic sclerosis

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.

Eligibility criteria: 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

Primary outcomes:
measure: Internal organ involvement
timeFrame: 2-year
Secondary outcomes:
measure: Interstitial lung disease
timeFrame: 2-year
measure: Interstitial lung disease-progression
timeFrame: 2-year
measure: Interstitial lung disease-Changes of FVC% from baseline
timeFrame: 2-year
measure: Interstitial lung disease-Changes of DLCO% from baseline
timeFrame: 2-year
measure: Pulmonary arterial hypertension by echocardiography
timeFrame: 2-year
measure: Pulmonary arterial hypertension by right heart catheterization (optional)
timeFrame: 2-year
measure: Abnormal cardiac function without other heart disease by echocardiography
timeFrame: 2-year
measure: Pericardial effusion wihtout other heart disease by echocardiography
timeFrame: 2-year
measure: Arrhythmia on electrocardiogram
timeFrame: 2-year
measure: University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Scale (UCLA SCTC GIT) 2.0
timeFrame: 2-year
measure: Scleroderma-Specific Health Assessment Questionnaire (SHAQ)
timeFrame: 2-year
measure: Short Form(SF)-36 Health Survey
timeFrame: 2-year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
name: Eun Bong Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gabrielli A, Avvedimento EV, Krieg T. Scleroderma. N Engl J Med. 2009 May 7;360(19):1989-2003. doi: 10.1056/NEJMra0806188. No abstract available.
citation: Galluccio F, Walker UA, Nihtyanova S, Moinzadeh P, Hunzelmann N, Krieg T, Steen V, Baron M, Sampaio-Barros P, Kayser C, Nash P, Denton CP, Tyndall A, Muller-Ladner U, Matucci-Cerinic M. Registries in systemic sclerosis: a worldwide experience. Rheumatology (Oxford). 2011 Jan;50(1):60-8. doi: 10.1093/rheumatology/keq355.