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Collecting DNA to Study Genes Linked to Vasculitis

Collects one DNA sample to find genes that raise vasculitis risk.

Key facts

Who runs it
University of Pennsylvania
Where
Istanbul, TürkiyeSee the siteAlso in 2 other countries, 13 sites
Trial code
Registry title
One-Time DNA Study for Vasculitis
Status
Recruiting
People taking part
1,000 people, planned
Started
Oct 2010
Expected to end
Aug 2028
Type of study
Observational
Record updated
22 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with certain types of vasculitis (inflamed blood vessels). They give one blood sample for a DNA study of genes that raise the risk of the disease.

Age
From 7 years. Giant cell arteritis needs disease onset after age 50; Takayasu's arteritis needs onset before age 50.
Sex
All sexes can join.
Disease stage
A diagnosis of giant cell arteritis, Takayasu's arteritis, polyarteritis nodosa, granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, or eosinophilic granulomatosis with polyangiitis (Churg-Strauss), shown by the criteria listed in the record.
Biomarker or test result
For granulomatosis with polyangiitis, one of the criteria is a positive ANCA test (PR3- or MPO-ANCA). All people must be willing to give blood for DNA collection.

Main reasons for not taking part

  • Cannot give informed consent and sign the consent form
  • Already enrolled in VCRC protocols 5502, 5503, 5504, 5505, 5506, 5522, or 5523
  • Unwilling to give blood for DNA collection

The registry criteria, word for word

Show all 38 criteriaShow less

Who can take part

  • 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
  • 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)
  • 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
  • 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
  • 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 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 in Türkiye

Also in 2 other countries, 13 sites

  • Istanbul UniversityIstanbul, TürkiyeContact: Carol McAlear, MANo longer taking part

About the trial

What the trial wants to find out

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 provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
VCRC Genetic Repository One-Time DNA Protocol
Plain-language title
Collecting DNA to Study Genes Linked to VasculitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 January 2026