SclerodermaNCT01656447
Scleroderma Registry & Repository at the Hospital for Special Surgery
An observational study of Scleroderma, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The overall objective of the Scleroderma Registry is to support and promote the basic science and clinical research of this complex rheumatic disease at the Hospital for Special Surgery (HSS). The registry facilitates our understanding of the clinical features, pathobiology, genetics of Scleroderma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scleroderma
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All individuals older than 18 years of age who have Scleroderma
Who may be able to join
- Individuals older than 18 years of age with Scleroderma
Who cannot join
- Individuals younger than 18 years of age
- Individuals older than 18 years of age without Scleroderma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Eliza Pelrine, BA, 212-774-2123, pelrinee@hss.edu
Robert Spiera, MD
About this study
Official title: The Scleroderma Registry & Repository
The overall objective of the Scleroderma Registry is to support and promote the basic science and clinical research of this complex rheumatic disease at the Hospital for Special Surgery (HSS). The registry facilitates our understanding of the clinical features, pathobiology, genetics of Scleroderma. This will ultimately lead to a potential treatment for this currently untreatable condition.
Read the detailed description
What will be asked of you:
- Completion of 2 health questionnaires
- Donation of research bloods. This is optional, but encouraged (if possible).
- We also encourage patients who come for initial visits to return so follow-up data can be collected.
Benefits to Patients:
- The HSS Scleroderma Registry gives patients the opportunity to participate in observational research with the goal of improving the lives of patients in the future.
- By donating research bloods and providing clinical information, patients will help generate new knowledge about Scleroderma that can guide the treatment and care of patients afflicted with this rare disease.
- Patients will also receive a comprehensive, medical evaluation from an HSS physician who specializes in treating Scleroderma. He or she will provide guidance on treatment options and recommendations for current or upcoming clinical trials.
- Physicians will also make patients aware of the resources available to them, including support groups and educational programs.
- Conditions
- Scleroderma
- Keywords
- Scleroderma, Scleroderma Registry, Hospital for Special Surgery Scleroderma
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Scleroderma | Patients who have been diagnosed at any point in their life with Scleroderma will compose the cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rodnan Skin Score
Physician score of skin thickening over 17 areas of the body.
Measured: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
Secondary outcomes (2)
Scleroderma Health Assessment Questionnaire
Patient questionnaire
Measured: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
Short Form-36
Patient questionnaire
Measured: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startAug 2006
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
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.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert F Spiera, MD, Principal investigator, Hospital for Special Surgery, New YorkJessica K Gordon, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656447
- Sponsor's protocol ID
- 2014-276
- Status last verified
- Oct 2025
- First submitted
- 1 Aug 2012
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Scleroderma Registry & Repository
- ClinicalTrials.gov ID
- NCT01656447
- Acronym / sponsor ID
- 2014-276
- Conditions
- Scleroderma
- Keywords
- Scleroderma, Scleroderma Registry, Hospital for Special Surgery Scleroderma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 3 Aug 2012 (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 overall objective of the Scleroderma Registry is to support and promote the basic science and clinical research of this complex rheumatic disease at the Hospital for Special Surgery (HSS). The registry facilitates our understanding of the clinical features, pathobiology, genetics of Scleroderma. This will ultimately lead to a potential treatment for this currently untreatable condition.
Detailed description
What will be asked of you:
- Completion of 2 health questionnaires
- Donation of research bloods. This is optional, but encouraged (if possible).
- We also encourage patients who come for initial visits to return so follow-up data can be collected.
Benefits to Patients:
- The HSS Scleroderma Registry gives patients the opportunity to participate in observational research with the goal of improving the lives of patients in the future.
- By donating research bloods and providing clinical information, patients will help generate new knowledge about Scleroderma that can guide the treatment and care of patients afflicted with this rare disease.
- Patients will also receive a comprehensive, medical evaluation from an HSS physician who specializes in treating Scleroderma. He or she will provide guidance on treatment options and recommendations for current or upcoming clinical trials.
- Physicians will also make patients aware of the resources available to them, including support groups and educational programs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Scleroderma | – | –Patients who have been diagnosed at any point in their life with Scleroderma will compose the cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals older than 18 years of age who have Scleroderma
Key inclusion criteria (1 listed)
- Individuals older than 18 years of age with Scleroderma
Key exclusion criteria (2 listed)
- Individuals younger than 18 years of age
- Individuals older than 18 years of age without Scleroderma
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: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
Physician score of skin thickening over 17 areas of the body.
2 secondary outcomes
Scleroderma Health Assessment Questionnaire
Time frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
Short Form-36
Time frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Scleroderma, Vasculitis, \& Myositis Center WebsiteLink provided by the sponsor.
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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.
Robert F Spiera, MD principal investigator
Hospital for Special Surgery, New York
Jessica K Gordon, MD principal investigator
Hospital for Special Surgery, New York
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 Hospital for Special Surgery, New York 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliza Pelrine, BA ((212)774-2123, pelrinee@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rodnan Skin Score (time frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 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 26 Nov 2025.