Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)

  • STATUS
    Recruiting
  • End date
    Apr 18, 2024
  • participants needed
    500
  • sponsor
    University of Pennsylvania
Updated on 18 April 2021
vasculitis
asthma
granulomatosis
eosinophils

Summary

Eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA) 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 EGPA, 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 EGPA.

Description

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.

Details
Condition Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
Clinical Study IdentifierNCT00315380
SponsorUniversity of Pennsylvania
Last Modified on18 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Eosinophilic Granulomatosis With Polyangiitis or Churg-Strauss Syndrome?
Do you have any of these conditions: Churg-Strauss Syndrome or Eosinophilic Granulomatosis With Polyangiitis?
Do you have any of these conditions: Churg-Strauss Syndrome or Eosinophilic Granulomatosis With Polyangiitis?
Do you have any of these conditions: Eosinophilic Granulomatosis With Polyangiitis or Churg-Strauss Syndrome?
Do you have any of these conditions: Churg-Strauss Syndrome or Eosinophilic Granulomatosis With Polyangiitis?
Do you have any of these conditions: Churg-Strauss Syndrome or Eosinophilic Granulomatosis With Polyangiitis?
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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