Systemic SclerosisNCT00668473
Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis
An observational study of Systemic Sclerosis, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Attendees of a tertiary care clinic
Who may be able to join
- Meet American College of Rheumatology criteria for systemic sclerosis
- Subjects with systemic sclerosis must have involvement proximal to the knee or elbow, excluding the face
- Persons with no chronic health conditions
Who cannot join
- Persons with systemic sclerosis as a result of being exposed to chemicals or drugs that can cause a sceroderma-like illness
- Persons with autoimmune diseases other than systemic sclerosis
- Persons treated with cyclophosphamide in the last 8 weeks
- Persons with active infections, including but not limited to hepatitis C, hepatitis B, and HIV
- Persons prone to bleeding because they are treated with medications that thin the blood or have a low platelet count
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospitals
Ann Arbor, Michigan, 48109
About this study
Official title: Endostatin and Other Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis
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.
Read the 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.
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis angiogenesis
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects with diffuse scleroderma | |
| 2 | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of endostatin in skin and serum
Measured: At time of of biopsy and blood draw
Secondary outcomes (1)
Level of JAM-A in skin and serum
Measured: At time of blood draw and skin biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startMay 2007
- Primary completionMay 2008
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristine Phillips, University of Michigan
- Investigators
- Kristine Phillips, MD, Principal investigator, University of MichiganJames R Seibold, MD, Principal investigator, University of MichiganAlisa E Koch, MD, Principal investigator, University of MichiganJulie A Konkle, BSN, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668473
- Sponsor's protocol ID
- HUM00011196
- Status last verified
- Oct 2016
- First submitted
- 25 Apr 2008
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endostatin and Other Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT00668473
- Acronym / sponsor ID
- HUM00011196
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis angiogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects with diffuse scleroderma |
| 2 | – | –Healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Attendees of a tertiary care clinic
Key inclusion criteria (3 listed)
- Meet American College of Rheumatology criteria for systemic sclerosis
- Subjects with systemic sclerosis must have involvement proximal to the knee or elbow, excluding the face
- Persons with no chronic health conditions
Key exclusion criteria (5 listed)
- Persons with systemic sclerosis as a result of being exposed to chemicals or drugs that can cause a sceroderma-like illness
- Persons with autoimmune diseases other than systemic sclerosis
- Persons treated with cyclophosphamide in the last 8 weeks
- Persons with active infections, including but not limited to hepatitis C, hepatitis B, and HIV
- Persons prone to bleeding because they are treated with medications that thin the blood or have a low platelet count
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of endostatin in skin and serum
Time frame: At time of of biopsy and blood draw
1 secondary outcome
Level of JAM-A in skin and serum
Time frame: At time of blood draw and skin biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
Related trials for Systemic Sclerosis
Not yet recruitingPhase 2
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
Scleroderma, Sclerodactyly
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Phillips, MD principal investigator
University of Michigan
James R Seibold, MD principal investigator
University of Michigan
Alisa E Koch, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of endostatin in skin and serum (time frame: At time of of biopsy and blood draw). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.