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

Status: Recruiting
Location: See all (38) locations...
Study Type: Observational [Patient Registry]
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 20
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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

• Healthy adult or child

Locations
United States
California
University of San Francisco
Recruiting
San Francisco
Florida
University of Florida
Recruiting
Gainesville
Georgia
Medical College of Georgia
Recruiting
Augusta
Illinois
Comer Children's Hospital
Recruiting
Chicago
Indiana
Riley Hospital for Children
Recruiting
Indianapolis
Kentucky
University of Louisville
Recruiting
Louisville
New Jersey
The Joseph M. Sanzari Children's Hospital
Recruiting
Hackensack
New York
Children's Hospital at Montefiore
Recruiting
Bronx
Ohio
Akron Children's Hospital
Recruiting
Akron
Texas
Texas Children's Hospital
Recruiting
Houston
Utah
University of Utah / Primary Children's Hospital
Recruiting
Salt Lake City
Washington
Seattle Children's Hospital
Recruiting
Seattle
Other Locations
Argentina
Hospital de Pediatría Garrahan
Recruiting
Buenos Aires
Canada
University of Calgary / Alberta Children's Hospital
Recruiting
Calgary
IIWK Health Centre
Recruiting
Halifax
London Health Sciences Centre
Recruiting
London
Children's Hospital of Eastern Ontario
Recruiting
Ottawa
Royal University Hospital
Recruiting
Saskatoon
Janeway Childrens Health and Rehabilitation Centre
Active, not recruiting
St. John's
Hospital for Sick Children
Recruiting
Toronto
BC Children's Hospital
Recruiting
Vancouver
Denmark
Rigshospitalet
Recruiting
Copenhagen
Germany
University Children's Hospital
Active, not recruiting
Munster
India
Sanjay Gandhi Post Graduate Institute
Recruiting
Lucknow
Italy
Meyer Children's Hospital of Florence
Completed
Florence
Russian Federation
Saint-Petersburg State Pediatric Medical University
Recruiting
Saint Petersburg
Serbia
Mother and Child Health Care Institute of Serbia
Recruiting
Belgrade
Thailand
Siriraj Hospital
Recruiting
Bangkok
United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Recruiting
Birmingham
Royal Hospital for Children
Recruiting
Glasgow
Leeds Children's Hospital
Recruiting
Leeds
Alder Hey Children's Hospital
Recruiting
Liverpool
Royal Manchester Children's Hospital
Recruiting
Manchester
Great North Children's Hospital
Recruiting
Newcastle Upon Tyne
Nottingham Children's Hospital
Recruiting
Nottingham
Nuffield Orthopaedic Centre
Recruiting
Oxford
Sheffield Children's Foundation Trust
Recruiting
Sheffield
Southampton General Hospital
Recruiting
Southampton
Contact Information
Primary
Else S. Bosman, PhD
pedvas@cw.bc.ca
Time Frame
Start Date: January 2013
Estimated Completion Date: March 2025
Participants
Target number of participants: 1600
Treatments
PEDIATRIC VASCULITIS/PROSPECTIVE
Pediatric patients in this cohort are those diagnosed with vasculitis within 12 months from study entry. Clinical data, blood (RNA, plasma, serum), urine, and saliva (DNA) will be collected at 3 to 5 timepoints: time-of-diagnosis, post-induction, 12-month post diagnosis, disease flare, and remission/post-flare.
PEDIATRIC VASCULITIS/RETROSPECTIVE
Patients in this cohort are those diagnosed with vasculitis more than 12 months from study entry and/or were previously enrolled in the ARChiVe or Brainworks registries. Clinical outcome data will be collected retrospectively. Blood (RNA & serum), urine, and saliva (DNA) will be collected at 2 timepoints: disease flare, and remission/post-flare.
ADULT VASCULITIS/ COHORT 1
Adult patients in this cohort are those at or near the time of diagnosis of GPA, MPA, EGPA or unclassified vasculitis that are participants in DCVAS. Clinical data and blood (RNA, DNA) will be collected at the time-of-diagnosis only.
ADULT VASCULITIS / COHORT 2
Adult patients in this cohort are those individuals that are participants in DCVAS and have any form of vasculitis. Clinical data and blood (DNA) collected at the time-of-diagnosis will be used for study.
HEALTHY CHILDREN / PEDIATRIC CONTROL
Participants in this cohort are otherwise healthy children with no history of inflammatory disease. Children will provide a one time donation of blood (RNA, serum) and urine.
HEALTHY ADULTS / ADULT CONTROL
Participants in this cohort are otherwise healthy adults with no history of inflammatory disease. Adults will provide a one time donation urine and will provide blood (RNA, serum) as many as 4 times.
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), University of Oxford, Simon Fraser University, University Hospital Muenster, Alberta Children's Hospital, The Hospital for Sick Children, Child and Family Research Institute
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov

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