Scleroderma Registry & Repository at the Hospital for Special Surgery
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Scleroderma Registry & Repository|
- Modified Rodnan Skin Score [ Time Frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years ] [ Designated as safety issue: No ]Physician score of skin thickening over 17 areas of the body.
- Scleroderma Health Assessment Questionnaire [ Time Frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years ] [ Designated as safety issue: No ]Patient questionnaire
- Short Form-36 [ Time Frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years ] [ Designated as safety issue: No ]Patient questionnaire
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.
|Study Start Date:||August 2006|
|Estimated Primary Completion Date:||January 2030 (Final data collection date for primary outcome measure)|
Patients with Scleroderma
Patients who have been diagnosed at any point in their life with Scleroderma will compose the cohort.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656447
|Contact: Eliza Pelrine, BA||(212)firstname.lastname@example.org|
|Contact: Chris Hatzis, BA||(212)email@example.com|
|United States, New York|
|Hospital for Special Surgery||Recruiting|
|New York, New York, United States, 10021|
|Contact: Eliza Pelrine, BA 212-774-2123 firstname.lastname@example.org|
|Principal Investigator: Robert Spiera, MD|
|Sub-Investigator: Jessica Gordon, MD|
|Principal Investigator:||Robert F Spiera, MD||Hospital for Special Surgery, New York|
|Principal Investigator:||Jessica K Gordon, MD||Hospital for Special Surgery, New York|