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Sponsors and Collaborators: |
Office of Rare Diseases (ORD) Rare Diseases Clinical Research Network |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00315380 |
Churg-Strauss Syndrome (CSS) is a rare immune system disorder that causes asthma, an excessive number of eosinophils (a type of white blood cell) in the blood, and the inflammation of blood vessels, or vasculitis. In order to properly treat CSS, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of this disease in people with CSS.
Condition |
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Churg-Strauss Syndrome |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Longitudinal Protocol for Churg-Strauss Syndrome |
Blood (serum and plasma), urine, and DNA
Estimated Enrollment: | 96 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | April 2016 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
CSS, also known as allergic granulomatosis angiitis, is a systemic vasculitis. CSS is marked by three distinct symptoms: asthma; eosinophilia, evidenced by an excessive number of eosinophils in the blood and tissues; and vasculitis involving the skin, lungs, nerves, kidneys, and other organs. Nerve involvement may also occur in CSS, causing pain, tingling, numbness, and muscle wasting in the hands and feet. Because CSS patients may not show any visible signs of active disease, current methods of monitoring disease progression usually represent a period of extended inflammation and disease activity. Thus, patients may go untreated during a period of undetectable disease when damage might be preventable. This study will use novel scientific methods to identify new biomarkers that can be used to monitor disease activity in CSS patients. These biomarkers may be used to help direct clinical care for CSS patients and assist in future drug development.
This study will last 5 years. Study visits will occur monthly for the first year, then every 3 months thereafter for the remainder of the study. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will occur every 3 months; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use. Participants may have additional study visits if a disease flare or disease-releated complications occur during the study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Individuals with Churg-Strauss Syndrome. Enrollment will be sequential and participants will have disease in various stages and of different duration.
Inclusion Criteria:
Documented evidence of small vessel vasculitis and at least 4 of the following 6 American College of Rheumatology (ACR) criteria for the diagnosis of Churg-Strauss syndrome:
Exclusion Criteria:
United States, Maryland | |
The Johns Hopkins Vasculitis Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Cynthia Bethea 410-550-4390 cbethea3@jhmi.edu | |
Principal Investigator: Philip Seo, MD, MHS | |
United States, Massachusetts | |
Boston University School of Medicine | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Jessica Martin 617-414-2507 jmartin@bu.edu | |
Principal Investigator: Peter A. Merkel, MD, MPH | |
Principal Investigator: Paul A. Monach, MD | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Kathy Mieras 507-284-9187 mieras.kathleen@mayo.edu | |
Principal Investigator: Ulrich Specks, MD | |
Principal Investigator: Steven R. Ytterberg, MD | |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Katherine Tuthill 216-444-5257 TUTHILLK@ccf.org | |
Principal Investigator: Carol A. Langford, MD, MHS | |
Canada, Ontario | |
Mount Sinai Hospital | Recruiting |
Toronto, Ontario, Canada | |
Contact: Sara Sutherland 416-586-8616 SSutherland2@mtsinai.on.ca | |
Principal Investigator: Simon Carette, MD | |
St. Joseph's Healthcare | Recruiting |
Hamilton, Ontario, Canada | |
Contact: Sandra Messier 905-522-1155 ext 35873 smessier@stjoes.ca | |
Principal Investigator: Nader A. Khalidi, MD |
Study Chair: | Peter A. Merkel, MD, MPH | Boston University |
Principal Investigator: | Carol A. Langford, MD, MHS | The Cleveland Clinic |
Principal Investigator: | Philip Seo, MD, MHS | Johns Hopkins Vasculitis Center |
Principal Investigator: | Ulrich Specks, MD | Mayo Clinic |
Principal Investigator: | Steven R. Yetterberg, MD | Mayo Clinic |
Responsible Party: | Boston University School of Medicine ( Peter A. Merkey, MD, MPH ) |
Study ID Numbers: | RDCRN 5506, U54RR019497, VCRC 5506 |
Study First Received: | April 14, 2006 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00315380 |
Health Authority: | United States: Federal Government |
CSS |
Lymphatic Diseases Vasculitis Churg-Strauss Syndrome Churg-Strauss syndrome |
Vascular Diseases Lymphoproliferative Disorders Granuloma |
Pathologic Processes Disease Syndrome Cardiovascular Diseases |