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 : May 17, 2022
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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
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| 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, California | |
| University of California San Diego | Recruiting |
| San Diego, California, United States, 92122 | |
| Contact: Damaris Diaz dad003@health.ucsd.edu | |
| Principal Investigator: Praveen Akuthota, MD | |
| United States, Colorado | |
| National Jewish Health | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Genna Frappaolo frappaolog@njhealth.org | |
| Principal Investigator: Michael Wechsler, MD | |
| 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: Michael Stachowitz stachowitz.michael@mayo.edu | |
| Principal Investigator: Ulrich Specks, MD | |
| Principal Investigator: Kenneth Warrington, 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 | Completed |
| Salt Lake City, Utah, United States, 84112 | |
| 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | May 17, 2022 |
| Last Verified: | May 2022 |
| 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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Systemic Vasculitis Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Granulomatosis with Polyangiitis Churg-Strauss Syndrome Vascular Diseases Cardiovascular Diseases Lung Diseases, Interstitial |
Lung Diseases Respiratory Tract Diseases Autoimmune Diseases Immune System Diseases Granuloma Lymphoproliferative Disorders Lymphatic Diseases |