Scleroderma Registry & Repository At the Hospital for Special Surgery

Recruiting

• Conditions: Scleroderma

• Registration Number: NCT01656447
• Lead Sponsor: Hospital for Special Surgery, New York

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.

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 Timeline

• Study Start: 2006-08
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-03
• Status Verified: 2023-10
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States