Pediatric Vasculitis Initiative



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 20
Updated:5/9/2018
Start Date:January 2013
End Date:December 2019
Contact:Angelyne Sarmiento
Email:pedvas@cw.bc.ca

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Chronic Childhood Vasculitis: Characterizing the Individual Rare Diseases to Improve Patient Outcomes

Childhood chronic vasculitis describes a group of rare life-threatening diseases that have in
common inflammation of blood vessels in vital organs such as kidneys, lungs and brain. Most
knowledge about them comes from adult patients. Severe disease requires aggressive
life-saving treatments with steroids and some cancer drugs which can themselves cause damage,
and increase risks of cancer and severe infections. Conversely, milder disease can be treated
with less toxic drugs. Different classification and "scoring tools" are used to define the
types and severity of vasculitis and to measure damage caused by disease or drugs. These in
turn help direct how aggressively to treat a patient and to measure outcome. None of these
tools however have been assessed in children and the best balance of disease and treatment
risks against outcome for children is not known. Although causes of these diseases in
children and adults are probably the same, the effects of the disease and the response (good
and bad) to drugs will differ in growing children. Because specialists may see only one new
child with vasculitis each year, obtaining enough information to learn about childhood
vasculitis requires cooperation. We will use an international web-based registry to which
doctors from 50 or more centers can contribute patient data. We will determine the features
which help better classify and diagnose children compared to adults. Through the web we will
collect and analyze information on patients similarly classified and "scored" so that most
successful treatments can be identified. Children with vasculitis are less likely to have
diseases associated with aging, alcohol and smoking etc., and therefore may be a better group
in whom to study the underlying biology of vasculitis. We will use this opportunity and
collect spit, blood and tissue from registry patients for laboratory study with an aim to
find biomarkers to better classify, define and direct optimal treatment and outcomes.

Over a 3-year period, we anticipate enrollment and collection of clinical data from as many
as 600 children with various forms of childhood vasculitis, with approximately one third
(200) of those children also contributing biological samples for study.

For children with vasculitis who are enrolled in the study, clinical information will be
obtained from the medical chart from the time of diagnosis, post-induction (3-6 months post
diagnosis) visit, 12-month clinic visit, and their most recent clinic visit or last clinic
visit before discharge to adult care (ie. final outcome visit). Information that will be
collected includes laboratory test results, biopsy and imaging results, disease activity,
clinical history, and medications. Blood, urine, and saliva samples will also be collected at
each clinic visit. If the subject experiences a disease flare, clinical data and biological
samples will be collected at the time of the flare and at a later date when the disease
remits.

The PedVas study is linked to an adult vasculitis initiative called DCVAS: Diagnosis and
Classification Criteria in Vasculitis. Our DCVAS co-investigators and collaborators will
recruit up to 250 adults at or near the time of diagnosis of the following forms of
vasculitis: GPA, MPA, EGPA, TA, and UCV. Clinical data will be collected as part of the DCVAS
study; this includes information such as laboratory test results, disease activity, and
clinical history. Blood will also be collected and analyzed in parallel with samples
collected from children with vasculitis. Finally, a DNA-biobank will be created and will
house samples from approximately 700 adults and representing all forms of vasculitis.
Recruitment will proceed according to DCVAS approved protocols and it will be conducted at
participating DCVAS centres after the patient has formally consented to participation in the
DCVAS study.

Healthy volunteers from the community will be recruited to participate in this study by word
of mouth and recruitment posters. Participation for children involves a one-time donation of
blood and a urine sample, while adults may donate blood and urine up to 4 times over the
course of 18 months.

All biological samples will be processed and analyzed in Vancouver at the Child and Family
Research Institute and at the University of British Columbia. Detailed data will be collected
in electronic format and include demographic variables, socioeconomic status, detailed
clinical history & physical findings, anthropometric measures, and measures of disease
activity. All data for systemic vasculitis patients will be directly entered at each site
into a secure, online, web-based data entry system called REDCap which is managed through the
data management centre at the University of British Columbia in Vancouver. All CNS vasculitis
data will be entered into the Brainworks database which is managed by the data management
team at the Hospital for Sick Kids in Toronto.

Inclusion criteria for vasculitis subjects:

- Diagnosed with ANCA-associated vasculitis (AAV: such as Granulomatosis with
Polyangiitis (GPA), Eosinophilic Granulomatosis with Polyangiitis (EGPA) and
Microscopic Polyangiitis (MPA)), Primary Angiitis of the Central Nervous System
(PACNS), Unclassified vasculitis, Takayasu's Arteritis (TA) or Polyarteritis Nodosa
(PAN) before age 18

Inclusion criteria for healthy controls:

- Healthy adult or child

Exclusion Criteria for vasculitis subjects:

- Diagnosed with other vasculitis subtypes not listed above

- More than 20 years of age

Exclusion criteria for healthy controls:

- Donated greater than 20 ml of blood in the previous three weeks

- Has an immune disorder or blood borne infectious diseases (such as HIV or Hepatitis)

- Has vasculitis, multiple sclerosis, diabetes, an autoimmune disease, a thyroid
condition, or other chronic conditions involving the heart, lungs, gut or kidney

- Has a previous history of anaemia or abnormal blood clotting

- Has a current or previous drug abuse problem
We found this trial at
13
sites
Hackensack, New Jersey 07601
Principal Investigator: Suzanne Li, MD
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Principal Investigator: Mary Toth, MD
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Melissa Elder, MD, PhD
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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598 Telfair Street
Augusta, Georgia 30912
Principal Investigator: Rita Jerath, MB ChB
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Augusta, GA
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Bronx, New York 10467
Principal Investigator: Dawn Wahezi, MD
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Bronx, NY
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Buenos Aires,
Principal Investigator: Ricardo Russo, MD
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Chicago, Illinois
Principal Investigator: Linda Wagner-Weiner
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Chicago, IL
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Eyal Muscal, MD
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Kathleen O'Neil
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Kenneth Schikler
University of Louisville The University of Louisville is a state supported research university located in...
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Salt Lake City, Utah 84132
Principal Investigator: Aimee Hersh, MD
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San Francisco, California 94143
Principal Investigator: Erica Lawson, MD
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Susan Shenoi
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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