SclerodermaNCT02887495
The Scleroderma Biorepository and Pathogenesis Study (STOP Scleroderma)
An observational study of Scleroderma, run by George Washington University at 1 site in United States.
Trial summary
The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers use clinical data and human biospecimens to investigate why scleroderma patients develop certain complications from their disease. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Scleroderma
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 2 Feb 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with scleroderma, raynauds, or with positive autoantibodies
Who may be able to join
- Age >18 years
- Able to give informed consent.
- Diagnosed with scleroderma or with positive autoantibodies
Who cannot join
- < 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Victoria K Shanmugam
Washington D.C., District of Columbia, 20037
About this study
The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers use clinical data and human biospecimens to investigate why scleroderma patients develop certain complications from their disease. Patients with confirmed scleroderma, raynauds or positive autoantibodies are invited to participate. This research may help us understand how to prevent and treat scleroderma and other diseases.
- Conditions
- Scleroderma
- Keywords
- scleroderma, biorepository
- Medical subject headings
- Scleroderma, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rodnan Skin Score
Measured: 10 years
Secondary outcomes (1)
Medsger Severity Score
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJul 2014
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Shanmugam, MD, George Washington University
- Investigators
- Victoria K Shanmugam, MD, Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887495
- Sponsor's protocol ID
- 051427
- Status last verified
- Jul 2022
- First submitted
- 3 Feb 2015
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Scleroderma Biorepository and Pathogenesis Study (STOP Scleroderma)
- ClinicalTrials.gov ID
- NCT02887495
- Acronym / sponsor ID
- 051427
- Conditions
- Scleroderma
- Keywords
- scleroderma, biorepository
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 2 Sep 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.
The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers use clinical data and human biospecimens to investigate why scleroderma patients develop certain complications from their disease. Patients with confirmed scleroderma, raynauds or positive autoantibodies are invited to participate. This research may help us understand how to prevent and treat scleroderma and other diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with scleroderma, raynauds, or with positive autoantibodies
Key inclusion criteria (3 listed)
- Age >18 years
- Able to give informed consent.
- Diagnosed with scleroderma or with positive autoantibodies
Key exclusion criteria (1 listed)
- < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Rodnan Skin Score
Time frame: 10 years
1 secondary outcome
Medsger Severity Score
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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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.
Victoria K Shanmugam, MD principal investigator
The George Washington University
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 Scleroderma, run by George Washington University at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 27 Jul 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Rodnan Skin Score (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2022; AzTrials last refreshed its copy on 29 Oct 2026.