Seoul National University Hospital Systemic Sclerosis Cohort

Systemic Sclerosis Clinical Trial

Official title:

Systemic Sclerosis Cohort in Seoul National University Hospital Single Center Prospective Cohort, of Patients With Systemic Sclerosis in Korea

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02819947
• Other study ID #: 2520140100
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 13, 2016
• Last updated: June 28, 2016
• Start date: March 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• This is an observational prospective study.
Investigators will get clinical information including gender, date of birth, height, weight, family history for systemic sclerosis, education, and symptoms of organ involvement of skin, lung, heart, gastrointestinal tract, kidney, musculoskeletal system and laboratory data. Investigators will evaluate nailbed capillary microscope, hand x-ray, 6 minute walk test, echocardiography, computed tomography of chest, pulmonary function test (FVC%, DLCO%), and electrocardiogram as baseline. Investigators permit replacement of previous results within one year from baseline. Participants in the cohort will be followed up annually and investigators will treat SSc patients according to their routine practice in the best interest of patents. Medications for other comorbid conditions are allowed.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Gabrielli A, Avvedimento EV, Krieg T. Scleroderma. N Engl J Med. 2009 May 7;360(19):1989-2003. doi: 10.1056/NEJMra0806188. Review. — View 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, Müller-Ladner U, Matucci-Cerinic M. Registries in systemic sclerosis: a worldwide experience. Rheumatolog — View Citation

Outcome

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