Scleroderma Registry & Repository at the Hospital for Special Surgery

Scleroderma Clinical Trial

Official title:

The Scleroderma Registry & Repository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01656447
• Other study ID #: 2014-276
• Status: Recruiting
• Start date: August 2006
• Est. completion date: January 2030

Study information

• Verified date: October 2023
• Source: Hospital for Special Surgery, New York
• Contact: Eliza Pelrine, BA
• Phone: (212)774-2123
• Email: pelrinee[@]hss.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This will ultimately lead to a potential treatment for this currently untreatable condition.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Scleroderma Health Assessment Questionnaire	Patient questionnaire	Baseline & follow-up visits during regularly scheduled appointments for up to 5 years
Secondary	Short Form-36	Patient questionnaire	Baseline & follow-up visits during regularly scheduled appointments for up to 5 years

External Links

•   Scleroderma, Vasculitis, & Myositis Center Website