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Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

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. Identifier: NCT00668473
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
Kristine Phillips, University of Michigan

Brief Summary:
We propose to examine several angiogenic/angiostatic mediators in the skin and serum of subjects with SSc and compare it to levels found in the skin and serum of healthy subjects.

Condition or disease
Systemic Sclerosis

Detailed Description:
Systemic sclerosis (SSc) is a connective tissue disease that is characterized by fibrosis of the skin and internal organs. One of the earliest pathologic changes in patients with SSc is damage to the blood vessels. Many abnormalities have been found in the inner layer of the blood vessel, the enothelial tissue. It is known that there are mediators in the blood and tissues of the body that affect the endothelial tissue. These are called angiogenic (promote blood vessel formation) and angiostatic (inhibit blood vessel formation) mediators. Many of these mediators have been examined in the peripheral blood of patients with SSc, but fewer of these mediators have been examined at the site of action, in the tissue near the microvasculature. We hypothesize that there are differences in the levels of angiogenic/angiostatic mediators between healthy subjects and subjects with SSc. In addition, we propose that there are differences at skin sites that have varying levels of involvement with SSc of these angiogenic/angiostatic factors in subjects with SSc.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Endostatin and Other Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis
Study Start Date : May 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Subjects with diffuse scleroderma
Healthy controls

Primary Outcome Measures :
  1. Level of endostatin in skin and serum [ Time Frame: At time of of biopsy and blood draw ]

Secondary Outcome Measures :
  1. Level of JAM-A in skin and serum [ Time Frame: At time of blood draw and skin biopsy ]

Biospecimen Retention:   Samples Without DNA
skin serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Attendees of a tertiary care clinic

Inclusion Criteria:

  1. Meet American College of Rheumatology criteria for systemic sclerosis
  2. Subjects with systemic sclerosis must have involvement proximal to the knee or elbow, excluding the face
  3. Persons with no chronic health conditions

Exclusion Criteria:

  1. Persons with systemic sclerosis as a result of being exposed to chemicals or drugs that can cause a sceroderma-like illness
  2. Persons with autoimmune diseases other than systemic sclerosis
  3. Persons treated with cyclophosphamide in the last 8 weeks
  4. Persons with active infections, including but not limited to hepatitis C, hepatitis B, and HIV
  5. Persons prone to bleeding because they are treated with medications that thin the blood or have a low platelet count

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 identifier (NCT number): NCT00668473

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United States, Michigan
University of Michigan Hospitals
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Principal Investigator: Kristine Phillips, MD University of Michigan
Principal Investigator: James R Seibold, MD University of Michigan
Principal Investigator: Alisa E Koch, MD University of Michigan
Study Director: Julie A Konkle, BSN University of Michigan

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Responsible Party: Kristine Phillips, clinical assistant professor, University of Michigan Identifier: NCT00668473     History of Changes
Other Study ID Numbers: HUM00011196
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Kristine Phillips, University of Michigan:
systemic sclerosis angiogenesis

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