RECRUITINGOBSERVATIONAL
One-Time DNA Study for Vasculitis
VCRC Genetic Repository One-Time DNA Protocol
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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
Who May Qualify:
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)
Who May Qualify:
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
Who May Qualify:
4\. Diagnostic criteria for Granulomatosis with Polyangiitis (Wegener's) (GPA) and Microscopic Polyangitis (MPA)
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Locations (14)
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Hospital for Special Surgery
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Istanbul University
Istanbul, Fatih, Turkey (Türkiye)