Home › Trials › NCT01241305

One-time DNA analysis for vasculitis

VCRC Genetic Repository One-Time DNA Protocol

Observational University of Pennsylvania · NCT01241305

This study is testing whether analyzing DNA from people with different types of vasculitis can help find genetic factors that increase the risk of these diseases and lead to better treatments.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages7 Years and up
SexAll
SponsorUniversity of Pennsylvania Academic / other
Locations14 sites (Los Angeles, California and 13 other locations)
Trial IDNCT01241305 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with specific types of vasculitis, such as Giant Cell Arteritis or Takayasu's Arteritis.

Not a fit: Patients with vasculitis types not included in the study or those who do not meet the diagnostic criteria may not benefit.

Why it matters

Potential benefit: If successful, this study could enhance understanding of vasculitis and lead to improved diagnostic and therapeutic options for patients.

How similar studies have performed: Other studies have shown promise in genetic research related to vasculitis, but this approach aims to expand on previous findings with a larger cohort.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Los Angeles, California and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Eosinophilic Granulomatosis With PolyangiitisGiant Cell ArteritisGranulomatosis With PolyangiitisMicroscopic PolyangiitisPolyarteritis NodosaTakayasu's ArteritisVasculitisCSS
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.