Pediatric Vasculitis Initiative

Recruiting

• Conditions: Wegeners Granulomatosis (Granulomatosis With Polyangiitis); Microscopic Polyangiitis; Polyarteritis Nodosa; Unclassified Vasculitis; Eosinophilic Granulomatosis With Polyangiitis; Takayasu Arteritis; Primary CNS Vasculitis

• Registration Number: NCT02006134
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

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.

All biological samples will be processed and analyzed in Vancouver at the BC Children's Hospital 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Develop new benchmarks for outcome in pediatric patients with systemic vasculitis	within 3 yrs	Specific and generic disease assessment tools will be used to analyze our registry cohorts to enable the first-ever benchmarks of outcome in children with GPA who have had a minimum of 12 months follow up.

Trial Locations

Locations (32)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

University of San Francisco; 🇺🇸 San Francisco, California, United States

University of Utah / Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States

Children's Hospital at Montefiore; 🇺🇸 Bronx, New York, United States

The Joseph M. Sanzari Children's Hospital; 🇺🇸 Hackensack, New Jersey, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

University Children's Hospital; 🇩🇪 Munster, Germany

Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Janeway Childrens Health and Rehabilitation Centre; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Comer Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Akron Children's Hospital; 🇺🇸 Akron, Ohio, United States

Alder Hey Children's Hospital; 🇬🇧 Liverpool, United Kingdom

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Birmingham Children's Hospital NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Great North Children's Hospital; 🇬🇧 Newcastle upon Tyne, United Kingdom

University of Calgary / Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Sanjay Gandhi Post Graduate Institute; 🇮🇳 Lucknow, India

Sheffield Children's Foundation Trust; 🇬🇧 Sheffield, United Kingdom

University of Florida; 🇺🇸 Gainesville, Florida, United States

Royal Hospital for Children; 🇬🇧 Glasgow, United Kingdom

Leeds Children's Hospital; 🇬🇧 Leeds, United Kingdom

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

IIWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Nottingham Children's Hospital; 🇬🇧 Nottingham, United Kingdom

Nuffield Orthopaedic Centre; 🇬🇧 Oxford, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Royal Manchester Children's Hospital; 🇬🇧 Manchester, United Kingdom