DNA hunt for vasculitis genes opens new doors
NCT ID NCT01241305
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study collects DNA samples and medical information from 1,000 people with various forms of vasculitis (blood vessel inflammation). Researchers will analyze the data to identify genes that increase the risk of developing these severe diseases. The goal is to better understand what causes vasculitis and to spark new ideas for diagnostic tests and treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Oct 2010
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Individuals with giant cell arteritis, Takayasu's arteritis, polyarteritis nodosa, granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss). Enrollment will be sequential and patients will have disease in various stages and of different duration.
- Ages
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7 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
COMPLETEDLos Angeles, California, 90048, United States
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Cleveland Clinic
COMPLETEDCleveland, Ohio, 44195, United States
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Hospital for Special Surgery
COMPLETEDNew York, New York, 10021, United States
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Istanbul University
COMPLETEDIstanbul, Fatih, 34452, Turkey (Türkiye)
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Mayo Clinic
COMPLETEDRochester, Minnesota, 55905, United States
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Mount Sinai Hospital
RECRUITINGToronto, Ontario, M5T 3L9, Canada
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Northwestern University
RECRUITINGChicago, Illinois, 60208, United States
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St. Joseph's Healthcare
RECRUITINGHamilton, Ontario, Canada
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University of California, San Francisco
COMPLETEDSan Francisco, California, 94143, United States
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University of Kansas Medical Center
COMPLETEDKansas City, Kansas, 66103, United States
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University of Michigan
COMPLETEDAnn Arbor, Michigan, 48109-5422, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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University of Pittsburgh
COMPLETEDPittsburgh, Pennsylvania, 15261, United States
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University of Utah
COMPLETEDSalt Lake City, Utah, 84132, United States
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Other studies related to the condition(s) this trial covers.
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