Expired Study
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Ann Arbor, Michigan 48109


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

HUM00011196


NCT ID:

NCT00668473


Secondary ID:


Study Acronym:


Brief Title:

Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis


Official Title:

Endostatin and Other Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kristine Phillips, MD
Principal Investigator
University of Michigan

Study Dates

Start Date:May 2007
Completion Date:January 2012
Completion Type:Actual
Primary Completion Date:May 2008
Primary Completion Type:Actual
Verification Date:October 2016
Last Changed Date:October 24, 2016
First Received Date:April 25, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Level of endostatin in skin and serum
Time Frame:At time of of biopsy and blood draw
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Level of JAM-A in skin and serum
Time Frame:At time of blood draw and skin biopsy
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Subjects with diffuse scleroderma
Study Arm Type:Other
Arm Name:2
Description:Healthy controls

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan

Samples and Retentions

Sample Retention:Samples Without DNA
Description: skin serum
Study Population: Attendees of a tertiary care clinic
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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