NCT02819947

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

May 13, 2016

Last Update Submit

June 28, 2016

Conditions

Systemic Sclerosis

Keywords

systemic sclerosiscohortKorean

Outcome Measures

Primary Outcomes (1)

  • Internal organ involvement

    Number of participants with internal organ involvement (Interstitial lung disease, Pulmonary arterial hypertension, Cardiac involvement, Gastrointestinal involvement, Renal involvement)

    2-year

Secondary Outcomes (12)

  • Interstitial lung disease

    2-year

  • Interstitial lung disease-progression

    2-year

  • Interstitial lung disease-Changes of FVC% from baseline

    2-year

  • Interstitial lung disease-Changes of DLCO% from baseline

    2-year

  • Pulmonary arterial hypertension by echocardiography

    2-year

  • +7 more secondary outcomes

Interventions

This is an observational prospective study.OTHER

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

SSc diagnosis according to 1980 or 2013 ACR classification criteria or 2001 criteria for the classification of early systemic sclerosis

You may qualify if:

  • SSc diagnosis according to 1980 or 2013 ACR classification criteria or 2001 criteria for the classification of early systemic sclerosis

You may not qualify if:

  • When patients refuse to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 19420368RESULT

  • 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.

    PMID: 21148153RESULT

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Eun Bong Lee, MD, PhD

    Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2016

First Posted

June 30, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 30, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)