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Trial record 1 of 6 for:    calcinosis scleroderma
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Calcinosis in a Single-Center Scleroderma Population (SSc-calcinosis)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02062125
Recruitment Status : Active, not recruiting
First Posted : February 13, 2014
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Vivien Hsu, M.D., Rutgers, The State University of New Jersey

Brief Summary:

This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how common and if there are any risk factors for having calcinosis

2) to identify common complications associated with scleroderma-related calcinosis.

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Condition or disease
Scleroderma Calcinosis

Detailed Description:

This is a prospective study of scleroderma- spectrum patients focused on soft tissue calcinosis in order 1) to better understand the risk factors (including clinical/laboratory characteristics, and serology) of calcinosis in the scleroderma-spectrum disorders (limited or diffuse systemic sclerosis with or without overlap of inflammatory arthritis and/or myositis).

2) view common complications associated with calcinosis.

Better understanding of scleroderma calcinosis would lead to other studies that eventually will define better treatment options for this incurable and often disabling complication.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders
Actual Study Start Date : October 2012
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2030





Primary Outcome Measures :
  1. risk factors and outcomes in scleroderma calcinosis [ Time Frame: 10 years ]

    This is an observational study of scleroderma calcinosis to assess possible risk factors (including serologic studies and disease types) as well as common complications that occur in those with scleroderma calcinosis during this time period. We will assess for increased burden of calcinosis with associated musculoskeletal complications from calcinosis over 10 years.

    No additional intervention will be delivered, other than standard of care for this complication.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult scleroderma subjects with and without calcinosis will be enrolled
Criteria

Inclusion Criteria:

  • Adult scleroderma subjects with and without calcinosis

Exclusion Criteria:

  • Subjects unwilling to participate

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): NCT02062125


Locations
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United States, New Jersey
RWJ Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Additional Information:

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Responsible Party: Vivien Hsu, M.D., Professor of Medicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02062125    
Other Study ID Numbers: Pro2012001886
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Vivien Hsu, M.D., Rutgers, The State University of New Jersey:
scleroderma
calcinosis
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Calcinosis
Connective Tissue Diseases
Skin Diseases
Calcium Metabolism Disorders
Metabolic Diseases