Scleroderma Registry & Repository at the Hospital for Special Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Scleroderma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Scleroderma Registry & Repository
Overview
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.
Primary outcome measures
- Modified Rodnan Skin Score [Time frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years]
Secondary outcome measures (2)
- Scleroderma Health Assessment Questionnaire [Time frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years]
- Short Form-36 [Time frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Hospital for Special Surgery — New York
Identifiers
NCT: NCT01656447 · 2014-276