Stimulatory Autoantibodies to the Platelet-Derived Growth Factor Receptor (PDGFR) and Phosphorylation of the Platelet-Derived Growth Factor Receptor (PDGFR) in Patients With Systemic Sclerosis
This study has been completed.
Information provided by (Responsible Party):
Kristine Phillips, University of Michigan
First received: April 23, 2008
Last updated: February 3, 2012
Last verified: February 2012
This study is to determine if subjects with systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening.
||Observational Model: Case Control
Time Perspective: Cross-Sectional
||Stimulatory Autoantibodies to the PDGFR and Phosphorylation of the PDGFR in Patients With Systemic Sclerosis
Primary Outcome Measures:
- Stimulatory autoantibodies to the PDGF receptor [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- Phosphorylation of the PDGF receptor in patients with systemic sclerosis [ Time Frame: One year ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2008 (Final data collection date for primary outcome measure)
Subjects with diffuse scleroderma
Subjects with limited scleroderma
Subjects without a fibrosing or autoimmune disease.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects from a tertiary care clinic specializing in scleroderma. Controls recruited by subjects being biopsied.
- Fulfill the American College of Rheumatology criteria for systemic sclerosis or:
- Have no diseases that result in primary fibrosis of an organ system, including the skin and do not have an autoimmune disease
- If the subject has systemic sclerosis resulting from an environmental exposure
- If the subject has an autoimmune disease excluding scleroderma
- If the subject has an active infection (including, but not limited to hepatitis B, hepatitis C and HIV)
- If the subject has been treated with cyclophosphamide in the past 8 weeks.
- If the subject is prone to bleeding because they are on medications that thin the blood or have a low platelet count.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00667134
|University of Michigan Medical School
|Ann Arbor, Michigan, United States, 48103 |
University of Michigan
||Kristine Phillips, MD
||University of Michigan
||Julie A Konkle, BSN
||University of Michigan
No publications provided
||Kristine Phillips, clinical assistant professor, University of Michigan
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 23, 2008
||February 3, 2012
||United States: Institutional Review Board
Keywords provided by University of Michigan:
systemic sclerosis autoantibodies
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Connective Tissue Diseases
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