Scleroderma Registry & Repository at the Hospital for Special Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01656447|
Recruitment Status : Recruiting
First Posted : August 3, 2012
Last Update Posted : March 15, 2018
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||The Scleroderma Registry & Repository|
|Study Start Date :||August 2006|
|Estimated Primary Completion Date :||January 2030|
Patients with Scleroderma
Patients who have been diagnosed at any point in their life with Scleroderma will compose the cohort.
- Modified Rodnan Skin Score [ Time Frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years ]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 ]Patient questionnaire
- Short Form-36 [ Time Frame: Baseline & follow-up visits during regularly scheduled appointments for up to 5 years ]Patient questionnaire
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656447
|Contact: Eliza Pelrine, BA||(212)firstname.lastname@example.org|
|Contact: Emily Bakaj, 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|