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Scleroderma Registry & Repository at the Hospital for Special Surgery

This study is currently recruiting participants.
Verified March 2017 by Hospital for Special Surgery, New York
Sponsor:
ClinicalTrials.gov Identifier:
NCT01656447
First Posted: August 3, 2012
Last Update Posted: March 15, 2017
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.
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
  Purpose
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.

Condition
Scleroderma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Scleroderma Registry & Repository

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

Estimated Enrollment: 300
Study Start Date: August 2006
Estimated Primary Completion Date: January 2030 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Scleroderma
Patients who have been diagnosed at any point in their life with Scleroderma will compose the cohort.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All individuals older than 18 years of age who have Scleroderma
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656447


Contacts
Contact: Eliza Pelrine, BA (212)774-2123 pelrinee@hss.edu
Contact: Emily Bakaj, BA (212)774-7620 bakaje@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Eliza Pelrine, BA    212-774-2123    pelrinee@hss.edu   
Principal Investigator: Robert Spiera, MD         
Sub-Investigator: Jessica Gordon, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Robert F Spiera, MD Hospital for Special Surgery, New York
Principal Investigator: Jessica K Gordon, MD Hospital for Special Surgery, New York
  More Information

Additional Information:
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01656447     History of Changes
Other Study ID Numbers: 26069
First Submitted: August 1, 2012
First Posted: August 3, 2012
Last Update Posted: March 15, 2017
Last Verified: March 2017

Keywords provided by Hospital for Special Surgery, New York:
Scleroderma
Scleroderma Registry
Hospital for Special Surgery Scleroderma

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases


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