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
  Purpose

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.


Condition
Systemic Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Endostatin and Other Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Level of endostatin in skin and serum [ Time Frame: At time of of biopsy and blood draw ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Level of JAM-A in skin and serum [ Time Frame: At time of blood draw and skin biopsy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

skin serum


Enrollment: 30
Study Start Date: May 2007
Groups/Cohorts
1
Subjects with diffuse scleroderma
2
Healthy controls

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Attendees of a tertiary care clinic

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00668473

Locations
United States, Michigan
University of Michigan Hospitals
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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
  More Information

No publications provided

Responsible Party: Michele L. Jaffe, MD, MPH, University of Michigan Medical School
ClinicalTrials.gov Identifier: NCT00668473     History of Changes
Other Study ID Numbers: HUM00011196
Study First Received: April 25, 2008
Last Updated: April 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
systemic sclerosis angiogenesis

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

ClinicalTrials.gov processed this record on August 18, 2014