NCT01241305Recruiting
One-Time DNA Study for Vasculitis
VCRC Genetic Repository One-Time DNA Protocol
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 22 Oct 2010
- Start date
- Oct 2010
- Primary completion date
- Aug 2028
- Lead sponsor
- University of Pennsylvania
- Diseases
- ANCA-associated vasculitis
- NCT number
- NCT01241305
What you commit to
- Study type: Observational
- Planned participants: 1000
- From Oct 2010 to the primary completion date, Aug 2028
- 14 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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 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
Age in the registry: 7 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Joseph's Healthcare Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Completed |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Completed |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Completed |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Completed |
| Hospital for Special Surgery Coordinator of this site? Confirm its status | New York | United States | Completed |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Completed |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Completed |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Completed |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Completed |
| Istanbul University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.