Seoul National University Hospital Systemic Sclerosis Cohort

• Conditions: Systemic Sclerosis

• Registration Number: NCT02819947
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-13
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-28
• Last Update Submitted: 2016-06-28
• Study First Posted: 2016-06-30
• Last Update Posted: 2016-06-30
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Internal organ involvement	2-year	Number of participants with internal organ involvement (Interstitial lung disease, Pulmonary arterial hypertension, Cardiac involvement, Gastrointestinal involvement, Renal involvement)

Secondary Outcome Measures

Name	Time	Method
Interstitial lung disease	2-year	Number of participants with ILD (at baseline and and during follow up) by computed tomography of chest
Pulmonary arterial hypertension by echocardiography	2-year	Number of participants with pulmonary arterial hypertension (PAH) by electrocardiography; -pulmonary arterial systolic pressure: 0-unlimited (mmHg)
Arrhythmia on electrocardiogram	2-year	Number of participants with arrhythmia on electrocardiogram
Interstitial lung disease-progression	2-year	Number of participants with progression of ILD from baseline by computed tomography of chest
Pulmonary arterial hypertension by right heart catheterization (optional)	2-year	Number of participants with PAH confirmed by right heart catheterization mean pulmonary arterial pressure: 0-unlimited (mmHg)
University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Scale (UCLA SCTC GIT) 2.0	2-year	0-3 scale (0: no GI problems to 3: most severe)
Scleroderma-Specific Health Assessment Questionnaire (SHAQ)	2-year	0-3 (where 0 = without difficulty and 3 = unable to do)
Short Form(SF)-36 Health Survey	2-year	0-100 scale (a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability)
Interstitial lung disease-Changes of FVC% from baseline	2-year	Changes of FVC% from baseline per year =FVC% at 1 year (0-unlimited%) - FVC% at baseline (0-unlimited%)
Interstitial lung disease-Changes of DLCO% from baseline	2-year	Changes of DLCO% from baseline per year =DLCO% at 1year (0-unlimited%) - DLCO% at baseline (0-unlimited%); * Negative value means improvement from baseline; * Positive value means deterioration from baseline
Abnormal cardiac function without other heart disease by echocardiography	2-year	Ejection fraction: 0-unlimited%
Pericardial effusion wihtout other heart disease by echocardiography	2-year	Pericardial effusion: mild, moderated, severe with hemodynamic unstability

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of