Scleroderma Registry & Repository at the Hospital for Special Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Scleroderma

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Eliza Pelrine, BA; Phone Number: (212)774-2123; Email: pelrinee@hss.edu
• Study Contact Backup: Name: Emily Bakaj, BA; Phone Number: (212)774-7620; Email: bakaje@hss.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Principal Investigator: Robert Spiera, MD
      • Contact: Eliza Pelrine, BA; Phone Number: 212-774-2123; Email: pelrinee@hss.edu
      • Sub-Investigator: Jessica Gordon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All individuals older than 18 years of age who have Scleroderma

Description

Inclusion Criteria:

• Individuals older than 18 years of age with Scleroderma

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rodnan Skin Score	Physician score of skin thickening over 17 areas of the body.	Baseline & follow-up visits during regularly scheduled appointments for up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scleroderma Health Assessment Questionnaire	Patient questionnaire	Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
Short Form-36	Patient questionnaire	Baseline & follow-up visits during regularly scheduled appointments for up to 5 years

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Robert F Spiera, MD, Hospital for Special Surgery, New York; Principal Investigator: Jessica K Gordon, MD, Hospital for Special Surgery, New York

Publications and helpful links

Helpful Links

• Scleroderma, Vasculitis, & Myositis Center Website

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimated): August 3, 2012

Study Record Updates

• Last Update Posted (Estimated): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Scleroderma; Scleroderma Registry; Hospital for Special Surgery Scleroderma
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 2014-276