One-time DNA analysis for vasculitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify genetic factors that increase the risk of developing various forms of vasculitis, which are severe inflammatory diseases affecting blood vessels. By collecting DNA samples from patients with specific types of vasculitis, researchers hope to gain insights into the underlying causes of these diseases. The findings could lead to new diagnostic tests and therapies, benefiting both vasculitis and broader autoimmune disease research. The study focuses on a range of vasculitis conditions, including Eosinophilic Granulomatosis With Polyangiitis and Giant Cell Arteritis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\. Diagnostic criteria for Giant Cell Arteritis Age at disease onset \>50 years (required)

1. New onset or new type of localized pain in the head
2. Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries)
3. ESR of \>40mm in the first hour by the Westergren method
4. 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)
5. Large Vessel Vasculitis (LVV) by angiogram or biopsy not explained by something else

Inclusion Criteria:

2\. Diagnostic criteria for Takayasu's Arteritis

1. Age at disease onset \<50 years
2. Claudication of extremities
3. Decreased brachial artery pulse (one or both arteries)
4. Blood pressure difference of \>10mm Hg between the arms
5. Bruit over subclavian arteries or aorta
6. Arteriogram abnormalities compatible with TAK (includes conventional dye angiography or MR angiography or CT angiography)

Inclusion Criteria:

3\. Diagnostic criteria for Polyarteritis Nodosa Major criteria (not explained by other causes) felt by investigator to be due to vasculitis

1. Arteriographic abnormality
2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy
3. Mononeuropathy or polyneuropathy

Minor criteria (not explained by other causes) felt by investigator to be due to vasculitis

1. Weight loss \> 4 kg
2. Livedo reticularis, cutaneous ulcerations, or skin nodules
3. Testicular pain or tenderness
4. Myalgias
5. Diastolic blood pressure \> 90 mm Hg
6. Elevated BUN or serum creatinine levels
7. Ischemic abdominal pain

Isolated cutaneous Polyarteritis Nodosa 1. Biopsy-proven cutaneous PAN

Inclusion Criteria:

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:

  1. Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood
  2. Abnormal chest radiograph with nodules, fixed infiltrates, or cavities
  3. Urinary sediment with microhematuria or red cell casts
  4. Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy
  5. 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:

  1. Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles)
  2. Necrotizing arteritis involving small- and medium-sized arteries may be present
  3. Necrotizing glomerulonephritis is very common
  4. Pulmonary capillaritis often occurs

     Inclusion Criteria:

     5\. Diagnostic criteria for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss)
     1. Asthma
     2. Peak peripheral blood eosinophilia of \>10% of total WBC
     3. Peripheral neuropathy attributable to vasculitis
     4. Transient pulmonary infiltrates on chest imaging studies
     5. Paranasal sinus abnormalities or nasal polyposis
     6. 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 Criteria:
* 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

Where it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• St. Joseph's Healthcare
  Hamilton, Ontario, Canada Recruiting
• Mount Sinai Hospital
  Toronto, Ontario, Canada Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Completed
• University of California, San Francisco
  San Francisco, California, United States Completed

Study contacts

• Study coordinator: Carol McAlear, MA
• Email: cmcalear@upenn.edu

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Collection of tissue samples for vasculitis research

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• Understanding the natural history and outcomes of systemic vasculitis

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• Global Takayasu Arteritis Registry (GITA)

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• How optic nerve swelling changes after starting steroids in giant cell arteritis

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  Recruiting Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Montreal, Quebec · NCT07508514

• Butantan live tetravalent dengue vaccine for people with autoimmune rheumatic diseases

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• Precision care for giant cell arteritis and polymyalgia rheumatica

  This long-term observational project will follow adults with giant cell arteritis or polymyalgia rheumatica to see if regular imaging, eye exams, blood tests, and immune cell profiling can better predict aortic complications and steroid side effects over 5–10 years.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.