Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-12 @ 6:51 AM
Study NCT ID:
NCT06417502
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D003882', 'term': 'Dermatomyositis'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017285', 'term': 'Polymyositis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-05-11', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Enrolled Patients', 'timeFrame': 'up to 10 years', 'description': 'Total number of patients with pediatric rheumatic and immunologic diseases enrolled in the registry'}], 'secondaryOutcomes': [{'measure': 'Physician Global Assessment', 'timeFrame': 'up to 10 years', 'description': 'Visual Analog Score measurement of disease activity by physicians. The minimum value is 0 and the maximum is 10.'}, {'measure': 'Patient or Parent Global Assessment', 'timeFrame': 'up to 10 years', 'description': "Visual Analog Score measurement of disease activity by patient's parent or patient him or her self (above 8 years old). The minimum value is 0 and the maximum is 10."}, {'measure': 'Proportion of Participants with Clinically Inactive Disease', 'timeFrame': 'up to 10 years', 'description': "Defined by normal disease activity indexes (if available) and normal inflammatory markers (erythrocyte sedimentation rate and C-reactive protein).\n\nDisease activity indexes include Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) for systemic lupus erythematosus; Juvenile Arthritis Disease Activity Score (JADAS)-27 for juvenile idiopathic arthritis, Pediatric Vasculitis Activity Score (PVAS) for vasculitis; Manual Muscle Testing(MMT)8, Childhood Myositis Assessment Scale (CMAS) for juvenile dermatomyositis, Sjögren's syndrome disease activity index (ESSDAI) for Sjögren's syndrome, Modified Rodnan Skin Score for scleroderma."}, {'measure': 'Childhood Health Assessment Questionnaire (CHAQ)', 'timeFrame': 'up to 10 years', 'description': 'Composite measure of functional disability, score from 0 (no disability) to 3 (severe disability)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus', 'Juvenile Idiopathic Arthritis', 'Vasculitis', 'Juvenile Dermatomyositis', "Sjogren's disease", 'Autoimmune', 'Autoinflammatory Disease', 'Scleroderma'], 'conditions': ['Autoimmune Diseases', 'Autoinflammatory Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://caprid.pumch.cn', 'label': 'The Official Website for Chinese Alliance of Pediatric Rheumatic \\& Immunologic Diseases (CAPRID)'}]}, 'descriptionModule': {'briefSummary': 'An observational, multi-center, longitudinal registry study for Chinese pediatric patients with rheumatic and immunologic diseases.', 'detailedDescription': 'Pediatric rheumatic and immunologic diseases severely impact the health of children and adolescents. Chinese Alliance of Pediatric Rheumatic \\& Immunologic Diseases (CAPRID) was founded in 2022 to form a national collaboration for high-quality data-driven multi-center pediatric rheumatology and immunology research in China. The CAPRID Registry is an observational, multi-center, longitudinal registry for Chinese pediatric patients with rheumatic and immunologic diseases to explore the clinical phenotypes, diagnoses, complications, real-world drug safety, therapeutic efficacy, adverse events, critical illness and outcomes of Chinese pediatric patients with rheumatic and immunologic diseases.\n\nHospital-based databases are established and standardized with Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) for routine data collection. A web-based registry website is established with standardized electronic case report forms to register patients from CAPRID centers. A mobile application is created to allow long-term follow up and patient-reported outcome collection. The data captured in this registry reflects a "real world" situation with no intervention done outside the routine clinical practice. Treatment plans are determined by the investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese children with pediatric rheumatic and immunologic diseases enrolled from CAPRID centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\<= 18 years old\n* Diagnosed with rheumatic and immunologic diseases (including diffuse connective tissue diseases, arthritis, vasculitis, inborn errors of immunity)\n* Diagnosed and Treated in China\n\nExclusion Criteria:\n\n* Disagreement of involving in this study by the patient or his/her family.'}, 'identificationModule': {'nctId': 'NCT06417502', 'briefTitle': 'Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry', 'orgStudyIdInfo': {'id': 'JS-3362D'}, 'secondaryIdInfos': [{'id': '2021YFC2702000', 'type': 'OTHER_GRANT', 'domain': 'National Key R&D Program of China'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongmei Song, MD, PhD', 'role': 'CONTACT', 'email': 'songhm1021@126.com', 'phone': '+86-10-69156271'}, {'name': 'Sihao Gao', 'role': 'CONTACT', 'email': 'sihao.gao@gmail.com', 'phone': '+86-10-69156271'}, {'name': 'Hongmei Song, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huawei Mao, MD, PhD', 'role': 'CONTACT'}], 'facility': "Beijing Children's Hospital, Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiqiang Yan, PhD', 'role': 'CONTACT'}], 'facility': 'Third Hospital of Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuemei Tang, MD', 'role': 'CONTACT'}], 'facility': "Chidren's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Yang, MD', 'role': 'CONTACT'}], 'facility': "Shenzhen Children's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wanling Yang, PhD', 'role': 'CONTACT'}], 'facility': 'The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaochuan Wu, MD', 'role': 'CONTACT'}], 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haiguo Yu, MD', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Nanjing Medical University", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meiping Lu, MD', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Zhejiang University School of Medicine", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Sihao Gao', 'role': 'CONTACT', 'email': 'sihao.gao@gmail.com', 'phone': '(+86) 010-6915-5727'}], 'overallOfficials': [{'name': 'Hongmei Song, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, {'name': 'Central South University', 'class': 'OTHER'}, {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, {'name': "Shenzhen Children's Hospital", 'class': 'OTHER_GOV'}, {'name': "Children's Hospital of Nanjing Medical University", 'class': 'OTHER'}, {'name': 'The University of Hong Kong', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Third Hospital of Peking University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Hongmei Song', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}