Scleroderma Registry & Repository at the Hospital for Special Surgery

NCT01656447 | Recruiting

• 1 other identifier: 2014-276
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scleroderma

Keywords

Scleroderma; Scleroderma Registry; Hospital for Special Surgery Scleroderma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Scleroderma Health Assessment Questionnaire

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

• Short Form-36

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

Study Arms (1)

Patients with Scleroderma

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All individuals older than 18 years of age who have Scleroderma

You may qualify if:

• Individuals older than 18 years of age with Scleroderma

You may not qualify if:

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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Related Links

• Scleroderma, Vasculitis, \& Myositis Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Research bloods will be collected if the patient gives permission. These bloods can be donated at the time of a patient's private visit with a physician at Hospital for Special Surgery, or at an independent research visit.

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Robert F Spiera, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

• Jessica K Gordon, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliza Pelrine, BA

CONTACT

(212)774-2123; pelrinee@hss.edu

Emily Bakaj, BA

CONTACT

(212)774-7620; bakaje@hss.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 3, 2012
• Study Start: August 1, 2006
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: November 26, 2025

Record last verified: 2025-10

Locations

US (1)