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Pediatric Vasculitis Initiative

NCT ID: NCT02006134

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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Vasculitis Primary CNS Vasculitis Systemic vasculitis Churg-Strauss Syndrome Polyarteritis Nodosa Wegener Granulomatosis Pediatric vasculitis Childhood vasculitis Granulomatosis with polyangiitis Microscopic Polyangiitis Takayasu Arteritis Autoimmune ANCA-associated vasculitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Diagnosed with other vasculitis subtypes not listed above
* More than 20 years of age


* 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
Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BC Childrens Hospital Research Institute

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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David Cabral

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Cabral, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia; BC Children's Hospital

Raashid Luqmani, DM FRCP(E)

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Dirk Foell, MD

Role: PRINCIPAL_INVESTIGATOR

Universität Münster

Robert Hancock, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Colin Ross, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of San Francisco

San Francisco, California, United States

Site Status RECRUITING

University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Comer Children's Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status RECRUITING

The Joseph M. Sanzari Children's Hospital

Hackensack, New Jersey, United States

Site Status RECRUITING

Children's Hospital at Montefiore

The Bronx, New York, United States

Site Status RECRUITING

Akron Children's Hospital

Akron, Ohio, United States

Site Status RECRUITING

Texas Children's Hospital

Houston, Texas, United States

Site Status RECRUITING

University of Utah / Primary Children's Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

University of Calgary / Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status RECRUITING

BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Janeway Childrens Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada

Site Status ACTIVE_NOT_RECRUITING

IIWK Health Centre

Halifax, Nova Scotia, Canada

Site Status RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status RECRUITING

Hospital for Sick Children

Toronto, Ontario, Canada

Site Status COMPLETED

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status COMPLETED

Rigshospitalet

Copenhagen, , Denmark

Site Status COMPLETED

University Children's Hospital

Münster, , Germany

Site Status ACTIVE_NOT_RECRUITING

Sanjay Gandhi Post Graduate Institute

Lucknow, , India

Site Status RECRUITING

Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, , United Kingdom

Site Status RECRUITING

Royal Hospital for Children

Glasgow, , United Kingdom

Site Status RECRUITING

Leeds Children's Hospital

Leeds, , United Kingdom

Site Status RECRUITING

Alder Hey Children's Hospital

Liverpool, , United Kingdom

Site Status RECRUITING

Royal Manchester Children's Hospital

Manchester, , United Kingdom

Site Status RECRUITING

Great North Children's Hospital

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Nottingham Children's Hospital

Nottingham, , United Kingdom

Site Status RECRUITING

Nuffield Orthopaedic Centre

Oxford, , United Kingdom

Site Status RECRUITING

Sheffield Children's Foundation Trust

Sheffield, , United Kingdom

Site Status RECRUITING

Southampton General Hospital

Southampton, , United Kingdom

Site Status RECRUITING

Countries

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Argentina Italy Mexico Russia Serbia Spain United States Canada Denmark Germany India Thailand United Kingdom

Central Contacts

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Else S. Bosman, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Related Links

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http://www.sickkids.ca/Research/Brainworks/the-brainworks-study/index.html

BrainWorks: The International Childhood CNS Vasculitis Outcome Study

https://research.ndorms.ox.ac.uk/public/dcvas/

DCVAS: Diagnostic and Classification Criteria in Vasculitis Study

Other Identifiers

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TR2-119188

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H12-00894

Identifier Type: -

Identifier Source: org_study_id