Pediatric Vasculitis Initiative (PedVas)
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|ClinicalTrials.gov Identifier: NCT02006134|
Recruitment Status : Recruiting
First Posted : December 10, 2013
Last Update Posted : November 8, 2022
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|Condition or disease|
|Wegeners Granulomatosis (Granulomatosis With Polyangiitis) Microscopic Polyangiitis Churg Strauss Syndrome (Eosinophilic Granulomatosis With Polyangiitis) Polyarteritis Nodosa Takayasu Arteritis Primary CNS Vasculitis Unclassified Vasculitis|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1600 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Chronic Childhood Vasculitis: Characterizing the Individual Rare Diseases to Improve Patient Outcomes|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||March 2025|
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.
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.
- Develop new benchmarks for outcome in pediatric patients with systemic or CNS vasculitis [ Time Frame: 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 or PACNS who have had a minimum of 12 months follow up.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||up to 20 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006134
|Contact: Else S. Bosman, PhDfirstname.lastname@example.org|
|Principal Investigator:||David Cabral, MBBS||University of British Columbia; BC Children's Hospital|
|Principal Investigator:||Raashid Luqmani, DM FRCP(E)||University of Oxford|
|Principal Investigator:||Dirk Foell, MD||University of Muenster|
|Principal Investigator:||Robert Hancock, PhD||University of British Columbia|
|Principal Investigator:||Colin Ross, PhD||University of British Columbia|
|Principal Investigator:||Jinko Graham, PhD||Simon Fraser University|
|Responsible Party:||David Cabral, Principle Investigator, University of British Columbia|
|Other Study ID Numbers:||
TR2-119188 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
|First Posted:||December 10, 2013 Key Record Dates|
|Last Update Posted:||November 8, 2022|
|Last Verified:||November 2022|
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