Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT06560606
Status:
RECRUITING
Last Update Posted:
2024-08-19
First Post:
2024-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
UCAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA, RNA, plasma, serum, cell'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4100}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prospectively collect essential clinical data elements from children with new onset JIA', 'timeFrame': 'Up to 24 months'}, {'measure': 'Evaluate clinical outcomes associated with the use of therapeutic agents in children with JIA', 'timeFrame': 'Up to 24 months'}, {'measure': 'Evaluate clinical outcomes associated with the de-prescribing of therapeutic agents in children with JIA', 'timeFrame': 'Up to 24 months'}, {'measure': 'Prospectively collect essential clinical data elements from children with extreme phenotypes of JIA.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Prospectively collect essential biological data elements from children with new onset JIA', 'timeFrame': 'Up to 24 months'}, {'measure': 'Evaluate biological outcomes associated with the use of therapeutic agents in children with JIA', 'timeFrame': 'Up to 24 months'}, {'measure': 'Evaluate biological outcomes associated with the de-prescribing of therapeutic agents in children with JIA', 'timeFrame': 'Up to 24 months'}, {'measure': 'Prospectively collect essential biological data elements from children with extreme phenotypes of JIA', 'timeFrame': 'Up to 12 months'}, {'measure': 'Prospectively collect essential socioeconomic data elements from children with new onset JIA', 'timeFrame': 'Up to 12 months'}, {'measure': 'Evaluate the socioeconomic impact associated with the use of therapeutic agents in children with JIA', 'timeFrame': 'Up to 12 months'}, {'measure': 'Evaluate the socioeconomic impact associated with the de-prescribing of therapeutic agents in children with JIA', 'timeFrame': 'Up to 24 months'}, {'measure': 'Prospectively collect essential socioeconomic data elements from children with extreme phenotypes of JIA', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis']}, 'descriptionModule': {'briefSummary': "Childhood arthritis is a chronic disabling disease. New medications called biologic therapies are now available to treat arthritis that target key biologic molecules that cause inflammation. Biologic therapies, while very effective in treating arthritis in children, may have serious side effects including infections and potentially cancers, and are very expensive and doctors don't know, which one to choose for which child. The investigators will develop tests that enable them to learn about the biology of each child's arthritis and be able to predict when and which biologic therapy to start and when to stop.", 'detailedDescription': 'UCAN CAN-DU is a multicenter observational cohort study that will collect prospective data from children with arthritis. Biologic samples, clinical data and patient reported outcomes will be collected.\n\nIn addition, the study will also include a health economics component which will include a number of complementary approaches for quantifying and comparing benefits and risks that promote evidence-based, patient centered health care. This will address both the personal and societal economic burden of disease and include qualitative methods to inform the measurement of preferences, economic and simulation modelling to assess the value of biomarker testing. The socioeconomic impact of biomarker based treatment will be evaluated.\n\nAll clinical, biological and patient-derived data will be collected at an aggregation point housed and managed by High Performance Computing 4 Health (HPC4Health), a private hospital-only secure cloud-computing service within Compute Canada and physically located at SickKids/UHN. These databases and apps include biospecimen data and data collected through the eHealth platform. This will enable the study team to share and integrate data in near real-time into analytic models throughout the study course; hence providing a near real-time feedback from bench to bedside and vice versa.\n\nThe analysis of the cohorts will help define and confirm the biologic pathways predictive of disease course, treatment response and disease remission. This knowledge will then be used to develop a comprehensive clinical predictive tool to guide effective and safe treatment of childhood arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from the patient population of a UCAN study site.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCohort 1: - Biologic Basis of JIA\n\n* ≤18 years\\*\n* Active objective arthritis suspected to be JIA or diagnosed with JIA within 6 months of enrolment\n* Treatment naïve except for NSAIDs, allowed to have received NSAIDS within 6 months of diagnosis\n\nCohort 2 - Start Biologics\n\n* JIA diagnosis as per ILAR criteria (all subtypes)\n* ≤18 years\\*\n* Active arthritis\n* For sJIA, active disease not necessarily with arthritis.\n* Time of start, restart or switch biologic therapy: e.g. failure, insufficient/partial response or intolerance\n\nCohort 3 - Stop Biologics\n\n* JIA diagnosis as per ILAR criteria (all subtypes)\n* ≤18 years\\*\n* Inactive disease\n* Discontinuing/tapering biologics for inactive disease\n\nCohort 4: Extreme Phenotypes\n\n* Unexplained systemic inflammation with arthritis/arthralgia as a part of manifestations\n* High suspicion of genetic contribution\n* Severely affected patients with difficult to control disease (ie failure of multiple biologics)\n\nExclusion Criteria:\n\nCohort 1 :\n\n* Arthritis explained by another diagnosis\n* Joint injections as previous treatment less than 4 weeks prior to enrollment\n\nCohort 2:\n\n* Arthritis explained by any other cause\n* Start on biologics as an indication for uveitis only\n\nCohort 3:\n\n\\- Tapering scheme \\> 12 months to complete biologics stop\n\nCohort 4:\n\n\\- Arthritis explained by another diagnosis'}, 'identificationModule': {'nctId': 'NCT06560606', 'acronym': 'UCAN CAN-DU', 'briefTitle': 'UCAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'UCAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease', 'orgStudyIdInfo': {'id': '1771'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1 - Biologic Basis of JIA', 'description': 'The objectives for this group are to help researchers look at childhood arthritis and determine which management approach is best for each individual child.\n\nTo be eligible for this group:\n\nParticipant must be ≤ 18 years of age at time of study enrollment. Participant is suspected to have JIA. Participant has not received any treatment other than non-steroidal anti-inflammatory drugs, such as acetaminophen.'}, {'label': 'Cohort 2 - Start Biologics', 'description': 'The objectives for this group are to help researchers develop a tool to predict response to therapy.\n\nTo be eligible for this group:\n\nParticipant ≤ 18 years of age at time of study enrollment. Participant has been diagnosed with JIA and arthritis is active. Participant will be starting, re-starting or switching to a new biologic therapy.'}, {'label': 'Cohort 3 - Stop Biologics', 'description': 'The objectives for this group are to help researchers develop a tool to predict who will remain in remission after discontinuing therapy.\n\nTo be eligible for this group:\n\nParticipant ≤ 18 years of age at time of study enrollment. Participant has been diagnosed with JIA and arthritis is inactive. Participant will be stopping or tapering biologic therapy.'}, {'label': 'Cohort 4: Extreme Phenotypes', 'description': 'The objective for this group is new gene discovery and drug target identification.\n\nTo be eligible for this group:\n\nThere is high suspicion of genetic contribution. Participants are severely affected with difficult to control arthritis or systemic disease.\n\nThere is unexplained systemic inflammation with arthritis/arthralgia as a part of manifestations'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paivi Miettunen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nicole Johnson, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Muhammed Dhalla, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Heinrike Schmeling, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marinka Twilt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rebeka Stevenson, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Susanne Benseler, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Deborah Marshall, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Alberta Children's Hospital - University of Calgary", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dax G Rumsey, MD, MSc, FRCP(C)', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniah Basodan, MBBS, FRCP(C)', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lillian Lim, MD, MPH, FRCP(C)', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tara McGrath, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Stollery Children's Hospital", 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lori Tucker, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrea Human, MD, MScHQ, FRCPC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Cabral, MBBS, FRCPC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jaime Guzman, MD, MSc, FRCPC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kim Morishita, MD, MHSc, FRCPC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kristin Houghton, MD, MSc, FRCPC, Dip Sports Med', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Herman Tam, MD, FRCPC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mercedes Chan, MBBS, MHPE, FRCPC', 'role': 'SUB_INVESTIGATOR'}], 'facility': "BC Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lily Lim, MBBS, MRCPCH, FRCPC, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Health Science Centre Winnipeg", 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paul Dancey, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Janeway Children's Hospital and Rehabilitation Centre", 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Adam Huber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bianca Lang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elizabeth Stringer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chelsea DeCoste, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Michelle Batthish, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tania Cellucci', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Liane Heale', 'role': 'SUB_INVESTIGATOR'}], 'facility': "McMaster Children's Hospital", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Roberta Berard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jonathan Park, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Erkan Demirkaya, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's Hospital, London Health Sciences Centre", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Michele Gibbon', 'role': 'CONTACT', 'email': 'mgibbon@cheo.on.ca'}, {'name': 'Ciaran Duffy, MB', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Roman Jurencak, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nadia Luca, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tala El Tal, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's Hospital of Eastern Ontario", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1E8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Shirley Tse, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Deborah Levy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ronald Laxer, MDCM', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Brian Feldman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dilan Dissanayake, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elizaveta Limenis, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ruud Verstegen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lynn Spiegel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Evelyn Rozenblyum, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jennifer JY Lee, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alisa Rachlis, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rae Yeung, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Claire LeBlanc, M.A, MD, FRCPC, Dip Sport Med', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gaelle Chedeville, MsC, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rosie Scuccimarri, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sarah Campillo, MD, FRCPC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Piya Lahiry, M.SC, PHD, MD, FRCPC', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Montréal Children's Hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S7N 5A2', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Alan Rosenberg', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mehul Jariwala', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tristan Kerr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kate Neufeld', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ellen Schatorjé, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Esther Hoppenreijs, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Amalia Children's Hospital, Radboudumc", 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '6574 NA', 'city': 'Boxmeer', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ellen Schatorjé, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Esther Hoppenreijs, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sint Maartenskinderkliniek', 'geoPoint': {'lat': 51.64667, 'lon': 5.94722}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Dieneke Schonenberg, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mariken Gruppen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Merlijn van den Berg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Giske Biesbroek, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Emma Children's Hospital, Amsterdam UMC", 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2333 ZA', 'city': 'Leiden', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Danielle Brinkman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Petra Hissink Muller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Willem-Alexander Children's Hospital, LUMC", 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '3015 CN', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Philomine van Pelt, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marleen Verkaaik, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sylvia Kamphuis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Sophia Children's Hospital, EMC", 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '9713 GZ', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Elisabeth Legger, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wineke Armbrust, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Beatrix Children's Hospital, UMCG", 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3584 EA', 'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Regina de Geus', 'role': 'CONTACT', 'email': 'r.degeus@umcutrecht.nl'}, {'name': 'Annet van Royen-Kerkhof, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bas Vastert, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Berent Prakken, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Erika VanNieuwenhove, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joost Swart, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marc Jansen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nico Wulffraat, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Wilhelmina Children's Hospital, UMCU", 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Alexander Mosoiu', 'role': 'CONTACT', 'email': 'alexander.mosiu@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '302495'}, {'name': 'Amy Xu', 'role': 'CONTACT', 'email': 'amy.xu@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '302495'}], 'overallOfficials': [{'name': 'Rae SM Yeung, MD, PhD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children (SickKids), University of Toronto'}, {'name': 'Nico Wulffraat, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Wilhelmina Children's Hospital, University Medical Center Utrecht"}, {'name': 'Susa Benseler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Alberta Children's Hospital and Cumming School of Medicine, University of Calgary"}, {'name': 'Joost Swart, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Wilhelmina Children's Hospital, University Medical Center Utrecht"}, {'name': 'Bas Vastert, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Wilhelmina Children's Hospital, University Medical Center Utrecht"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Data sharing requests will continuously be reviewed on a case-to-case basis. Time frames will be according to the most DAAC terms of reference and governance rules.', 'ipdSharing': 'YES', 'description': 'Data Access Advisory Committee (DAAC) has been formed. The DAAC is an advisory body tasked with guiding, developing and implementing principals for data sharing and policy for data access, including development of subcommittees to be formed to review request for secondary analysis or secondary or ancillary projects. The DAAC reports to the Executive Committee.\n\nIPD will only be shared at the summary level and de-identified.', 'accessCriteria': 'The DAAC will review the requests for access to clinical data and biologic data/samples collected through the UCAN CAN-DU project for the purposes of addressing secondary research questions. Assessments include, but not limited to, scientific merits, research environment, potential impact and significance, feasibility, overlap with other research questions, financial plan, and involvement with patient partners.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Genome Canada', 'class': 'OTHER'}, {'name': 'Genome Alberta', 'class': 'OTHER'}, {'name': 'The Arthritis Society, Canada', 'class': 'OTHER'}, {'name': 'ReumaNederland', 'class': 'UNKNOWN'}, {'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}, {'name': "Alberta Children's Hospital", 'class': 'OTHER'}, {'name': 'Ontario Genomics', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Staff Physician and Senior Scientist', 'investigatorFullName': 'Rae Yeung', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}