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Status:

RECRUITING

One-Time DNA Study for Vasculitis

Lead Sponsor:

University of Pennsylvania

Collaborating Sponsors:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Office of Rare Diseases (ORD)

Conditions:

Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)

Giant Cell Arteritis

Eligibility:

All Genders

7+ years

Brief Summary

The purpose of this study is to identify genes that increase the risk of developing vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results of these studies will pro...

Detailed Description

The systemic vasculitides comprise several inflammatory diseases of blood vessels, usually arteries, which may cause systemic, multi-organ disease that can result in substantial morbidity and increase...

Eligibility Criteria

Inclusion

  • 1\. Diagnostic criteria for Giant Cell Arteritis Age at disease onset \>50 years (required)
  • New onset or new type of localized pain in the head
  • Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries)
  • ESR of \>40mm in the first hour by the Westergren method
  • Abnormal artery biopsy (i.e. temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells)
  • Large Vessel Vasculitis (LVV) by angiogram or biopsy not explained by something else
  • 2\. Diagnostic criteria for Takayasu's Arteritis
  • Age at disease onset \<50 years
  • Claudication of extremities
  • Decreased brachial artery pulse (one or both arteries)
  • Blood pressure difference of \>10mm Hg between the arms
  • Bruit over subclavian arteries or aorta
  • Arteriogram abnormalities compatible with TAK (includes conventional dye angiography or MR angiography or CT angiography)
  • 3\. Diagnostic criteria for Polyarteritis Nodosa Major criteria (not explained by other causes) felt by investigator to be due to vasculitis
  • Arteriographic abnormality
  • Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy
  • Mononeuropathy or polyneuropathy
  • Minor criteria (not explained by other causes) felt by investigator to be due to vasculitis
  • Weight loss \> 4 kg
  • Livedo reticularis, cutaneous ulcerations, or skin nodules
  • Testicular pain or tenderness
  • Myalgias
  • Diastolic blood pressure \> 90 mm Hg
  • Elevated BUN or serum creatinine levels
  • Ischemic abdominal pain
  • Isolated cutaneous Polyarteritis Nodosa 1. Biopsy-proven cutaneous PAN
  • 4\. Diagnostic criteria for Granulomatosis with Polyangiitis (Wegener's) (GPA) and Microscopic Polyangitis (MPA)
  • Diagnosis of GPA or MPA. Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, have not been developed for GPA \& MPA.
  • For diagnosis of GPA meets at least 2 of the following 5 modified ACR criteria:
  • Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood
  • Abnormal chest radiograph with nodules, fixed infiltrates, or cavities
  • Urinary sediment with microhematuria or red cell casts
  • Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy
  • Antineutrophil cytoplasmic antibody (ANCA) positive by enzyme immunoassay for either PR3- or MPO-ANCA
  • For diagnosis of MPA, meets the Chapel Hill Consensus Conference Definition for MPA:
  • Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles)
  • Necrotizing arteritis involving small- and medium-sized arteries may be present
  • Necrotizing glomerulonephritis is very common
  • Pulmonary capillaritis often occurs
  • 5\. Diagnostic criteria for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss)
  • Asthma
  • Peak peripheral blood eosinophilia of \>10% of total WBC
  • Peripheral neuropathy attributable to vasculitis
  • Transient pulmonary infiltrates on chest imaging studies
  • Paranasal sinus abnormalities or nasal polyposis
  • Eosinophilic inflammation on tissue biopsy
  • If patients have 4 of the above 6 criteria but lack clearcut documentation of small vessel vasculitis, they are also eligible for enrollment.
  • General

Exclusion

  • Inability to give informed consent and to sign the consent form
  • Enrolled in VCRC protocols 5502, 5503, 5504, 5505, 5506, 5522, or 5523
  • Unwilling to provide blood for DNA collection

Key Trial Info

Start Date :

October 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2027

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT01241305

Start Date

October 1 2010

End Date

August 1 2027

Last Update

June 12 2025

Active Locations (14)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (14 locations)

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

2

University of California, San Francisco

San Francisco, California, United States, 94143

3

Northwestern University

Chicago, Illinois, United States, 60208

4

University of Kansas Medical Center

Kansas City, Kansas, United States, 66103