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Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00668473
First received: April 25, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 25, 2008
April 25, 2008
May 2007
 
Level of endostatin in skin and serum [ Time Frame: At time of of biopsy and blood draw ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Level of JAM-A in skin and serum [ Time Frame: At time of blood draw and skin biopsy ] [ Designated as safety issue: No ]
Same as current
 
 
 
Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis
Endostatin and Other Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

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. 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.
 
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Retention:   Samples Without DNA
Description:

skin serum
Non-Probability Sample

Attendees of a tertiary care clinic
Systemic Sclerosis
 
  • 1
    Subjects with diffuse scleroderma
  • 2
    Healthy controls
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
 
 

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00668473
HUM00011196
No
Michele L. Jaffe, MD, MPH, University of Michigan Medical School
University of Michigan
 
Principal Investigator: Michele L Jaffe University of Michigan
Principal Investigator: James R Seibold, MD University of Michigan
Principal Investigator: Alisa E Koch, MD University of Michigan
University of Michigan
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP