Systemic SclerosisNCT02819947
Seoul National University Hospital Systemic Sclerosis Cohort
An observational study of Systemic Sclerosis, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- This is an observational prospective study.
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Jun 2018
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SSc diagnosis according to 1980 or 2013 ACR classification criteria or 2001 criteria for the classification of early systemic sclerosis
Who may be able to join
- SSc diagnosis according to 1980 or 2013 ACR classification criteria or 2001 criteria for the classification of early systemic sclerosis
Who cannot join
- When patients refuse to take part in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: Systemic Sclerosis Cohort in Seoul National University Hospital Single Center Prospective Cohort, of Patients With Systemic Sclerosis in Korea
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.
Read the 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.
- Conditions
- Systemic Sclerosis
- Being tested
- This is an observational prospective study.
- Keywords
- systemic sclerosis, cohort, Korean
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal organ involvement
Number of participants with internal organ involvement (Interstitial lung disease, Pulmonary arterial hypertension, Cardiac involvement, Gastrointestinal involvement, Renal involvement)
Measured: 2-year
Secondary outcomes (12)
Interstitial lung disease
Number of participants with ILD (at baseline and and during follow up) by computed tomography of chest
Measured: 2-year
Interstitial lung disease-progression
Number of participants with progression of ILD from baseline by computed tomography of chest
Measured: 2-year
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%)
Measured: 2-year
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
Measured: 2-year
Pulmonary arterial hypertension by echocardiography
Number of participants with pulmonary arterial hypertension (PAH) by electrocardiography
-pulmonary arterial systolic pressure: 0-unlimited (mmHg)
Measured: 2-year
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)
Measured: 2-year
Abnormal cardiac function without other heart disease by echocardiography
Ejection fraction: 0-unlimited%
Measured: 2-year
Pericardial effusion wihtout other heart disease by echocardiography
Pericardial effusion: mild, moderated, severe with hemodynamic unstability
Measured: 2-year
Arrhythmia on electrocardiogram
Number of participants with arrhythmia on electrocardiogram
Measured: 2-year
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)
Measured: 2-year
Scleroderma-Specific Health Assessment Questionnaire (SHAQ)
0-3 (where 0 = without difficulty and 3 = unable to do)
Measured: 2-year
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)
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Bong Lee, Seoul National University Hospital
- Investigators
- Eun Bong Lee, MD, PhD, Principal investigator, Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819947
- Sponsor's protocol ID
- 2520140100
- Status last verified
- Jun 2016
- First submitted
- 13 May 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19420368Galluccio 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.
PubMed 21148153
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Sclerosis Cohort in Seoul National University Hospital Single Center Prospective Cohort, of Patients With Systemic Sclerosis in Korea
- ClinicalTrials.gov ID
- NCT02819947
- Acronym / sponsor ID
- 2520140100
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, cohort, Korean
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SSc diagnosis according to 1980 or 2013 ACR classification criteria or 2001 criteria for the classification of early systemic sclerosis
Key inclusion criteria (1 listed)
- SSc diagnosis according to 1980 or 2013 ACR classification criteria or 2001 criteria for the classification of early systemic sclerosis
Key exclusion criteria (1 listed)
- When patients refuse to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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)
12 secondary outcomes
Interstitial lung disease
Time frame: 2-year
Interstitial lung disease-progression
Time frame: 2-year
Interstitial lung disease-Changes of FVC% from baseline
Time frame: 2-year
Interstitial lung disease-Changes of DLCO% from baseline
Time frame: 2-year
Pulmonary arterial hypertension by echocardiography
Time frame: 2-year
Pulmonary arterial hypertension by right heart catheterization (optional)
Time frame: 2-year
Abnormal cardiac function without other heart disease by echocardiography
Time frame: 2-year
Pericardial effusion wihtout other heart disease by echocardiography
Time frame: 2-year
Arrhythmia on electrocardiogram
Time frame: 2-year
University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Scale (UCLA SCTC GIT) 2.0
Time frame: 2-year
Scleroderma-Specific Health Assessment Questionnaire (SHAQ)
Time frame: 2-year
Short Form(SF)-36 Health Survey
Time frame: 2-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Results publication: PubMed 19420368Gabrielli A, Avvedimento EV, Krieg T. Scleroderma. N Engl J Med. 2009 May 7;360(19):1989-2003. doi: 10.1056/NEJMra0806188. No abstract available.
- Results publication: PubMed 21148153Galluccio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Bong Lee, MD, PhD principal investigator
Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal organ involvement (time frame: 2-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819947, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.