Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00315380 |
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Recruitment Status :
Recruiting
First Posted : April 18, 2006
Last Update Posted : April 13, 2021
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| Condition or disease |
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| Eosinophilic Granulomatosis With Polyangiitis Churg-Strauss Syndrome |
EGPA, also known as allergic granulomatosis angiitis, is a systemic vasculitis. EGPA 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 EGPA, causing pain, tingling, numbness, and muscle wasting in the hands and feet. Because EGPA 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 EGPA patients. These biomarkers may be used to help direct clinical care for EGPA patients and assist in future drug development.
Study visits will occur every 6 months, or annually. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Longitudinal Protocol for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) |
| Study Start Date : | April 2006 |
| Estimated Primary Completion Date : | April 2024 |
| Estimated Study Completion Date : | April 2024 |
- Discover biomarkers in EGPA capable of measuring disease activity and response to treatment [ Time Frame: Study completion ]
- Measure the predictive value of biomarkers for clinical outcome in EGPA [ Time Frame: Study completion. ]
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Patients with a diagnosis of eosinophilic granulomatosis with polyangiitis are eligible for the study.
Parent or guardian willing to provide informed consent, if applicable
Exclusion Criteria:
- Inability to give informed consent and to sign the consent form
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315380
| United States, Massachusetts | |
| Brigham and Women's Hospital | Completed |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Sam Hughes Hughes.Samantha@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: Loretta Williams WILLIAL34@ccf.org | |
| Principal Investigator: Carol A. Langford, MD, MHS | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Sarah Hopkins Sarah.Hopkins@Pennmedicine.upenn.edu | |
| Principal Investigator: Peter Merkel, MD, MPH | |
| University of Pittsburgh | Completed |
| Pittsburgh, Pennsylvania, United States, 15260 | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Jessica gonzalez jessica.gonzalez@hsc.utah.edu | |
| Principal Investigator: Curry Koening, MD, MHS | |
| Canada, Ontario | |
| 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 | |
| Mount Sinai Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Suneet Khurana Suneet.Khurana@sinaihealth.ca | |
| Principal Investigator: Christian Pagnoux, MD, MS | |
| Study Chair: | Peter A. Merkel, MD, MPH | University of Pennsylvania |
Publications:
| Responsible Party: | Peter Merkel, Professor, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00315380 |
| Other Study ID Numbers: |
VCRC5506 |
| First Posted: | April 18, 2006 Key Record Dates |
| Last Update Posted: | April 13, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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EGPA CSS |
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Churg-Strauss Syndrome Granulomatosis with Polyangiitis Systemic Vasculitis Vasculitis Vascular Diseases Cardiovascular Diseases Lung Diseases, Interstitial Lung Diseases |
Respiratory Tract Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Immune System Diseases Granuloma Lymphoproliferative Disorders Lymphatic Diseases |