Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)NCT01241305
One-Time DNA Study for Vasculitis
An observational study of Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) and Giant Cell Arteritis, run by University of Pennsylvania at 14 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss), Giant Cell Arteritis, Granulomatosis With Polyangiitis (Wegener's)
- How many people
- 1,000 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Oct 2010to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 51Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
14 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Carol McAlear, MA contact
14 sites in 3 countries
United States11 sites, 2 recruiting
- Completed
University of Michigan
Ann Arbor, Michigan, 48109-5422
- Recruiting
Northwestern University
Chicago, Illinois, 60208
John Seagrist, john.seagrist@northwestern.edu
- Completed
Cleveland Clinic
Cleveland, Ohio, 44195
- Completed
University of Kansas Medical Center
Kansas City, Kansas, 66103
- Completed
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Completed
Hospital for Special Surgery
New York, New York, 10021
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Daniel Killion, DKillion@Pennmedicine.upenn.edu
Peter Merkel, MD, MPH
- Completed
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
- Completed
Mayo Clinic
Rochester, Minnesota, 55905
- Completed
University of Utah
Salt Lake City, Utah, 84132
- Completed
University of California, San Francisco
San Francisco, California, 94143
Canada2 sites, 2 recruiting
- Recruiting
St. Joseph's Healthcare
Hamilton, Ontario
Sandra Messier, 905-522-1155 ext. 35873, smessier@stjoes.ca
Nader Khalidi, MD
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5T 3L9
Nazrana Haq, Nazrana.Haq@sinaihealth.ca
Christian Pagnoux, MD
Turkey (Türkiye)1 site
- Completed
Istanbul University
Istanbul, Fatih, 34452
About this study
Official title: VCRC Genetic Repository One-Time DNA Protocol
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.
Read the detailed description
The systemic vasculitides comprise several inflammatory diseases of blood vessels, usually arteries, which may cause systemic, multi-organ disease that can result in substantial morbidity and increased mortality. Each type of vasculitis is a rare ("orphan") disease. However, taken together, vasculitis affects tens of thousands of Americans and is responsible for substantial morbidity and mortality and almost one billion dollars per year in hospital care alone. While the vasculitides share the trait of vascular inflammation, the unique disease phenotypes, clinical courses, differences in prognoses, and responses to therapy suggest that important differences exist in pathogenesis. The Vasculitis Clinical Research Consortium (VCRC) currently focuses on 6 specific types of vasculitis that were selected to represent a balance between unmet medical and scientific needs, prevalence in North America, feasibility of study, and an interest in studying a spectrum of small, medium, and large vessel vasculitides.
The great majority of published studies on the genetics of vasculitis have used modest-sized cohorts that are only suitable for investigation of a few candidate genes at a time, or to detect large effect sizes, so that replicated findings are highly skewed to the HLA region. Larger and more ambitious genetic studies in vasculitis are expected to generate numerous hypotheses for translational research in gene expression, biochemistry, and molecular pathology.
A one-time collection of clinical data and DNA would substantially increase the sample sizes for genetic association studies in all six vasculitides studied in the VCRC. Many patients are seen at participating VCRC centers but do not enroll in the Longitudinal Studies. These patients often are interested in participating in research studies but cannot return frequently for visits, usually due to distance from the VCRC centers. This approach would be particularly useful for the rarer forms of vasculitis under study (Takayasu's Arteritis (TAK), Polyarteritis Nodosa (PAN), eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA) and also for Giant Cell Arteritis (GCA), since elderly patients have been particularly likely to decline participation in the Longitudinal Studies due to travel constraints.
- Conditions
- Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss), Giant Cell Arteritis, Granulomatosis With Polyangiitis (Wegener's), Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu's Arteritis
- Keywords
- Vasculitis, CSS, EGPA, GCA, GPA, WG, MPA, PAN, TAK
- Medical subject headings
- Churg-Strauss Syndrome, Giant Cell Arteritis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu Arteritis, Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical data and linked DNA specimens.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Rare Diseases (ORD), Rare Diseases Clinical Research Network
- Responsible party
- Principal investigator, Peter Merkel, University of Pennsylvania
- Investigators
- Peter Merkel, MD, MPH, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241305
- Sponsor's protocol ID
- VCRC5510
- Other IDs
- U54AR057319-06
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2010
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Doubelt I, Springer JM, Kermani TA, Sreih AG, Burroughs C, Cuthbertson D, Carette S, Khalidi NA, Koening CL, Langford C, McAlear CA, Moreland LW, Monach PA, Shaw DG, Seo P, Specks U, Warrington KJ, Young K, Merkel PA, Pagnoux C. Self-Reported Data and Physician-Reported Data in Patients With Eosinophilic Granulomatosis With Polyangiitis: Comparative Analysis. Interact J Med Res. 2022 May 25;11(1):e27273. doi: 10.2196/27273.
PubMed 35612893
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VCRC Genetic Repository One-Time DNA Protocol
- ClinicalTrials.gov ID
- NCT01241305
- Acronym / sponsor ID
- VCRC5510
- Conditions
- Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss), Giant Cell Arteritis, Granulomatosis With Polyangiitis (Wegener's), Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu's Arteritis
- Keywords
- Vasculitis, CSS, EGPA, GCA, GPA, WG, MPA, PAN
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Rare Diseases (ORD), Rare Diseases Clinical Research Network
- Study start
- Oct 2010
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The systemic vasculitides comprise several inflammatory diseases of blood vessels, usually arteries, which may cause systemic, multi-organ disease that can result in substantial morbidity and increased mortality. Each type of vasculitis is a rare ("orphan") disease. However, taken together, vasculitis affects tens of thousands of Americans and is responsible for substantial morbidity and mortality and almost one billion dollars per year in hospital care alone. While the vasculitides share the trait of vascular inflammation, the unique disease phenotypes, clinical courses, differences in prognoses, and responses to therapy suggest that important differences exist in pathogenesis. The Vasculitis Clinical Research Consortium (VCRC) currently focuses on 6 specific types of vasculitis that were selected to represent a balance between unmet medical and scientific needs, prevalence in North America, feasibility of study, and an interest in studying a spectrum of small, medium, and large vessel vasculitides.
The great majority of published studies on the genetics of vasculitis have used modest-sized cohorts that are only suitable for investigation of a few candidate genes at a time, or to detect large effect sizes, so that replicated findings are highly skewed to the HLA region. Larger and more ambitious genetic studies in vasculitis are expected to generate numerous hypotheses for translational research in gene expression, biochemistry, and molecular pathology.
A one-time collection of clinical data and DNA would substantially increase the sample sizes for genetic association studies in all six vasculitides studied in the VCRC. Many patients are seen at participating VCRC centers but do not enroll in the Longitudinal Studies. These patients often are interested in participating in research studies but cannot return frequently for visits, usually due to distance from the VCRC centers. This approach would be particularly useful for the rarer forms of vasculitis under study (Takayasu's Arteritis (TAK), Polyarteritis Nodosa (PAN), eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA) and also for Giant Cell Arteritis (GCA), since elderly patients have been particularly likely to decline participation in the Longitudinal Studies due to travel constraints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (51 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of clinical data and linked DNA specimens.
Time frame: 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 35612893Doubelt I, Springer JM, Kermani TA, Sreih AG, Burroughs C, Cuthbertson D, Carette S, Khalidi NA, Koening CL, Langford C, McAlear CA, Moreland LW, Monach PA, Shaw DG, Seo P, Specks U, Warrington KJ, Young K, Merkel PA, Pagnoux C. Self-Reported Data and Physician-Reported Data in Patients With Eosinophilic Granulomatosis With Polyangiitis: Comparative Analysis. Interact J Med Res. 2022 May 25;11(1):e27273. doi: 10.2196/27273.
- Vasculitis Clinical Research ConsortiumLink provided by the sponsor.
- Rare Diseases Clinical Research NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carol McAlear, MA contact
Peter Merkel, MD, MPH study director
University of Pennsylvania
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) and Giant Cell Arteritis, run by University of Pennsylvania at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 51 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol McAlear, MA (cmcalear@upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of clinical data and linked DNA specimens. (time frame: 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01241305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.