Pediatric Vasculitis Initiative

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages N/A - 20 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02006134
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of British Columbia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Cabral, MBBSSusanne Benseler, MD, PhDRaashid Luqmani, DM FRCP(E)Dirk Foell, MDRobert Hancock, PhDColin Ross, PhDJinko Graham, PhD
Principal Investigator Affiliation University of British Columbia; BC Children's HospitalAlberta Children's HospitalUniversity of OxfordUniversity of MuensterUniversity of British ColumbiaUniversity of British ColumbiaSimon Fraser University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherOtherOtherOtherOther
Overall Status Recruiting
Countries Argentina, Canada, Denmark, Germany, India, Italy, Mexico, Russian Federation, Serbia, Spain, Thailand, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Wegeners Granulomatosis (Granulomatosis With Polyangiitis), Microscopic Polyangiitis, Churg Strauss Syndrome (Eosinophilic Granulomatosis With Polyangiitis), Polyarteritis Nodosa, Takayasu Arteritis, Primary CNS Vasculitis, Unclassified Vasculitis
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of San Francisco, San Francisco, California

Status

Recruiting

Address

University of San Francisco

San Francisco, California,

Site Contact

pedvas@cw.bc.ca

University of Florida, Gainesville, Florida

Status

Recruiting

Address

University of Florida

Gainesville, Florida,

Site Contact

pedvas@cw.bc.ca

Medical College of Georgia, Augusta, Georgia

Status

Recruiting

Address

Medical College of Georgia

Augusta, Georgia,

Site Contact

pedvas@cw.bc.ca

Comer Children's Hospital, Chicago, Illinois

Status

Not yet recruiting

Address

Comer Children's Hospital

Chicago, Illinois,

Site Contact

pedvas@cw.bc.ca

Riley Hospital for Children, Indianapolis, Indiana

Status

Recruiting

Address

Riley Hospital for Children

Indianapolis, Indiana,

Site Contact

pedvas@cw.bc.ca

University of Louisville, Louisville, Kentucky

Status

Recruiting

Address

University of Louisville

Louisville, Kentucky,

Site Contact

pedvas@cw.bc.ca

Hackensack, New Jersey

Status

Recruiting

Address

The Joseph M. Sanzari Children's Hospital

Hackensack, New Jersey,

Site Contact

pedvas@cw.bc.ca

Children's Hospital at Montefiore, Bronx, New York

Status

Recruiting

Address

Children's Hospital at Montefiore

Bronx, New York,

Site Contact

pedvas@cw.bc.ca

Akron Children's Hospital, Akron, Ohio

Status

Recruiting

Address

Akron Children's Hospital

Akron, Ohio,

Site Contact

pedvas@cw.bc.ca

Texas Children's Hospital, Houston, Texas

Status

Not yet recruiting

Address

Texas Children's Hospital

Houston, Texas,

Site Contact

pedvas@cw.bc.ca

Salt Lake City, Utah

Status

Recruiting

Address

University of Utah / Primary Children's Hospital

Salt Lake City, Utah,

Site Contact

pedvas@cw.bc.ca

Seattle Children's Hospital, Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital

Seattle, Washington,

Site Contact

pedvas@cw.bc.ca

International Sites

Hospital de Pediatría Garrahan, Buenos Aires, Argentina

Status

Recruiting

Address

Hospital de Pediatría Garrahan

Buenos Aires, ,

Site Contact

pedvas@cw.bc.ca

Calgary, Alberta, Canada

Status

Recruiting

Address

University of Calgary / Alberta Children's Hospital

Calgary, Alberta,

Site Contact

pedvas@cw.bc.ca

BC Children's Hospital, Vancouver, British Columbia, Canada

Status

Recruiting

Address

BC Children's Hospital

Vancouver, British Columbia,

Site Contact

pedvas@cw.bc.ca

St. John's, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Janeway Childrens Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador,

Site Contact

pedvas@cw.bc.ca

IIWK Health Centre, Halifax, Nova Scotia, Canada

Status

Recruiting

Address

IIWK Health Centre

Halifax, Nova Scotia,

Site Contact

pedvas@cw.bc.ca

London Health Sciences Centre, London, Ontario, Canada

Status

Recruiting

Address

London Health Sciences Centre

London, Ontario,

Site Contact

pedvas@cw.bc.ca

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Status

Recruiting

Address

Children's Hospital of Eastern Ontario

Ottawa, Ontario,

Site Contact

pedvas@cw.bc.ca

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Recruiting

Address

Hospital for Sick Children

Toronto, Ontario,

Site Contact

pedvas@cw.bc.ca

Royal University Hospital, Saskatoon, Saskatchewan, Canada

Status

Recruiting

Address

Royal University Hospital

Saskatoon, Saskatchewan,

Site Contact

pedvas@cw.bc.ca

Rigshospitalet, Copenhagen, Denmark

Status

Recruiting

Address

Rigshospitalet

Copenhagen, ,

Site Contact

pedvas@cw.bc.ca

University Children's Hospital, Munster, Germany

Status

Recruiting

Address

University Children's Hospital

Munster, ,

Site Contact

pedvas@cw.bc.ca

Sanjay Gandhi Post Graduate Institute, Lucknow, India

Status

Recruiting

Address

Sanjay Gandhi Post Graduate Institute

Lucknow, ,

Site Contact

pedvas@cw.bc.ca

Meyer Children's Hospital of Florence, Florence, Italy

Status

Recruiting

Address

Meyer Children's Hospital of Florence

Florence, ,

Site Contact

pedvas@cw.bc.ca

Instituto Nacional de Pediatria, Coyoacán, Mexico

Status

Not yet recruiting

Address

Instituto Nacional de Pediatria

Coyoacán, ,

Site Contact

pedvas@cw.bc.ca

Saint Petersburg, Russian Federation

Status

Recruiting

Address

Saint-Petersburg State Pediatric Medical University

Saint Petersburg, ,

Site Contact

pedvas@cw.bc.ca

Belgrade, Serbia

Status

Recruiting

Address

Mother and Child Health Care Institute of Serbia

Belgrade, ,

Site Contact

pedvas@cw.bc.ca

Hospital Sant Joan de Deu, Barcelona, Spain

Status

Not yet recruiting

Address

Hospital Sant Joan de Deu

Barcelona, ,

Site Contact

pedvas@cw.bc.ca

Siriraj Hospital, Bangkok, Thailand

Status

Recruiting

Address

Siriraj Hospital

Bangkok, ,

Site Contact

pedvas@cw.bc.ca

Birmingham, United Kingdom

Status

Recruiting

Address

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, ,

Royal Hospital for Children, Glasgow, United Kingdom

Status

Recruiting

Address

Royal Hospital for Children

Glasgow, ,

Leeds Children's Hospital, Leeds, United Kingdom

Status

Recruiting

Address

Leeds Children's Hospital

Leeds, ,

Alder Hey Children's Hospital, Liverpool, United Kingdom

Status

Recruiting

Address

Alder Hey Children's Hospital

Liverpool, ,

Royal Manchester Children's Hospital, Manchester, United Kingdom

Status

Recruiting

Address

Royal Manchester Children's Hospital

Manchester, ,

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

Status

Recruiting

Address

Great North Children's Hospital

Newcastle upon Tyne, ,

Nottingham Children's Hospital, Nottingham, United Kingdom

Status

Recruiting

Address

Nottingham Children's Hospital

Nottingham, ,

Site Contact

pedvas@cw.bc.ca

Nuffield Orthopaedic Centre, Oxford, United Kingdom

Status

Recruiting

Address

Nuffield Orthopaedic Centre

Oxford, ,

Sheffield Children's Foundation Trust, Sheffield, United Kingdom

Status

Recruiting

Address

Sheffield Children's Foundation Trust

Sheffield, ,

Southampton General Hospital, Southampton, United Kingdom

Status

Recruiting

Address

Southampton General Hospital

Southampton, ,

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