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RecruitingNCT01656447Updated Nov 26, 2025

Scleroderma Registry & Repository at the Hospital for Special Surgery

An observational study in Scleroderma, sponsored by Hospital for Special Surgery, New York. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by Hospital for Special Surgery, New York · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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. 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.
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Conditions studied

  • Scleroderma

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Keywords

  • Scleroderma
  • Scleroderma Registry
  • Hospital for Special Surgery Scleroderma
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In context

Scleroderma, Diffuse

310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.

This study's planned enrollment of 300 is above the median of 113 across 68 observational studies indexed under Scleroderma, Diffuse.

Browse Scleroderma, Diffuse studies →

Lead sponsor

Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All individuals older than 18 years of age who have Scleroderma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals older than 18 years of age with Scleroderma

Exclusion criteria

Exclusion Criteria:

  • Individuals younger than 18 years of age
  • Individuals older than 18 years of age without Scleroderma
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with Scleroderma

    Patients who have been diagnosed at any point in their life with Scleroderma will compose the cohort.

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What researchers measure

Primary outcomes

  1. Modified Rodnan Skin Score

    Physician score of skin thickening over 17 areas of the body.

    Time frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years

Secondary outcomes

  1. Scleroderma Health Assessment Questionnaire

    Patient questionnaire

    Time frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years

  2. Short Form-36

    Patient questionnaire

    Time frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years

07

Study locations

1 of 1 sites recruiting
  • Hospital for Special Surgery
    New York, New York 10021, United States
    Recruiting
    • Eliza Pelrine, BA · Contactpelrinee@hss.edu · 212-774-2123
    • Robert Spiera, MD · Principal investigator
    • Jessica Gordon, MD · Sub investigator
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01656447
Responsible party
Sponsor
First posted
Aug 3, 2012
Start date
Aug 2006
Primary completion
Jan 2030 (estimated)
Completion
Jan 2030 (estimated)
Last update
Nov 26, 2025

Study contacts

Eliza Pelrine, BA
Contact
pelrinee@hss.edu
(212)774-2123
Emily Bakaj, BA
Contact
bakaje@hss.edu
(212)774-7620
Robert F Spiera, MD
principal investigator · Hospital for Special Surgery, New York
Jessica K Gordon, MD
principal investigator · Hospital for Special Surgery, New York

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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