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The Scleroderma Biorepository and Pathogenesis Study (STOP Scleroderma)

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ClinicalTrials.gov Identifier: NCT02887495
Recruitment Status : Recruiting
First Posted : September 2, 2016
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Victoria Shanmugam, George Washington University

Brief Summary:
The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers use clinical data and human biospecimens to investigate why scleroderma patients develop certain complications from their disease. Patients with confirmed scleroderma, raynauds or positive autoantibodies are invited to participate. This research may help us understand how to prevent and treat scleroderma and other diseases.

Condition or disease
Scleroderma

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2014
Estimated Primary Completion Date : July 2024





Primary Outcome Measures :
  1. Modified Rodnan Skin Score [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Medsger Severity Score [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with scleroderma, raynauds, or with positive autoantibodies
Criteria

Inclusion Criteria:

  • Age >18 years
  • Able to give informed consent.
  • Diagnosed with scleroderma or with positive autoantibodies

Exclusion Criteria:

  • < 18 years old

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): NCT02887495


Contacts
Contact: Viictoria K Shanmugam, MD 202-741-2488 vshanmugam@mfa.gwu.edu
Contact: Sean M McNish, MS 202-994-8567 mcnish@gwu.edu

Locations
United States, District of Columbia
Victoria K Shanmugam Recruiting
Washington, District of Columbia, United States, 20037
Contact: Victoria K Shanmugam, MD    202-741-2488    vshanmugam@mfa.gwu.edu   
Contact: Sean M McNish, MS    202-994-8567    mcnish@gwu.edu   
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: Victoria K Shanmugam, MD The George Washington University

Responsible Party: Victoria Shanmugam, Associate Professor of Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT02887495     History of Changes
Other Study ID Numbers: 051427
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

Keywords provided by Victoria Shanmugam, George Washington University:
scleroderma
biorepository

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