Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-23 @ 3:08 PM
Study NCT ID:
NCT07083466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Composite Inflammatory Ratios in Juvenile Idiopathic Arthritis and Their Association With Disease Activity
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001772', 'term': 'Blood Cell Count'}], 'ancestors': [{'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'possibility to use crp to albumin level as novel biomarker to predict disease activity in juvenile 0idiopathic arthritis', 'timeFrame': '6 months'}, {'measure': 'possibility to detect systemic inflammatory index and its relation to disease activity and risk of flare in juvenile idiopathic arthritis', 'timeFrame': '6 months'}, {'measure': 'assessment of activity of disease according to JDAS SCORE', 'timeFrame': '6 months'}, {'measure': 'assessment of neutrophils to albumin ratio and its relation to JDAS score activity score', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis']}, 'referencesModule': {'references': [{'pmid': '22483423', 'type': 'BACKGROUND', 'citation': 'Huang JL. New advances in juvenile idiopathic arthritis. Chang Gung Med J. 2012 Jan-Feb;35(1):1-14. doi: 10.4103/2319-4170.106171.'}, {'pmid': '21684384', 'type': 'BACKGROUND', 'citation': 'Prakken B, Albani S, Martini A. Juvenile idiopathic arthritis. Lancet. 2011 Jun 18;377(9783):2138-49. doi: 10.1016/S0140-6736(11)60244-4.'}, {'pmid': '15115702', 'type': 'BACKGROUND', 'citation': 'Milovanovic M, Nilsson E, Jaremo P. Relationships between platelets and inflammatory markers in rheumatoid arthritis. Clin Chim Acta. 2004 May;343(1-2):237-40. doi: 10.1016/j.cccn.2003.12.030.'}, {'pmid': '30316204', 'type': 'BACKGROUND', 'citation': 'Erre GL, Paliogiannis P, Castagna F, Mangoni AA, Carru C, Passiu G, Zinellu A. Meta-analysis of neutrophil-to-lymphocyte and platelet-to-lymphocyte ratio in rheumatoid arthritis. Eur J Clin Invest. 2019 Jan;49(1):e13037. doi: 10.1111/eci.13037. Epub 2018 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'Juvenile Idiopathic Arthritis (JIA) is a prevalent pediatric rheumatic disorder characterized by persistent inflammation of one or more joints in children and adolescents. This chronic condition is a major contributor to both short- and long-term morbidity and functional disability We aim in this study to investigate the role of CAR, PLR, NLR ,systemic inflammatory index (SII ) and NAR ( SII and NAR have never been evaluated before in JIA patients ) as potential markers of disease activity in patients with non-systemic JIA (nsJIA) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include 60 patients classified as JIA according International League of Associations for Rheumatology ILAR criteria on treatment who will recruited from Rheumatology and Rehabilitation department at Sohag University hospital in addition to 30 healthy individual volunteers without history of any systemic active disease recruited from the community as age and sex matched controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\n1\\. Patients who classified JIA according to International League of Associations for Rheumatology ILAR criteria on treatment with exclusion of systemic JIA.\n\n2\\. Patients with disease duration more than 6 months. 3. Age below 16 years old. 4. Patient cooperative and can answer questions. 5. Patients who are able and willing to give written informed consent or their parents/guardians\n\nExclusion Criteria:\n\n* 1\\. Systemic JIA. 2. Patients with other autoimmune or autoinflammatory diseases, immunodeficiencies, hematologic conditions, malignances and infectious disease at enrollment time or in the previous 2 weeks.\n\nPatients who are not able and willing to give written informed consent'}, 'identificationModule': {'nctId': 'NCT07083466', 'briefTitle': 'Assessment of Composite Inflammatory Ratios in Juvenile Idiopathic Arthritis and Their Association With Disease Activity', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Assessment of Composite Inflammatory Ratios in Juvenile Idiopathic Arthritis and Their Association With Disease Activity', 'orgStudyIdInfo': {'id': 'Soh-Med-25-6-6MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'case', 'description': 'cases under 16y established diagnosis juvenile idiopathic arthritis', 'interventionNames': ['Diagnostic Test: complete blood count', 'Diagnostic Test: serum albumin']}, {'label': 'control', 'description': 'below age 16 y not diagnosed with any autoimmune or systemic disease', 'interventionNames': ['Diagnostic Test: complete blood count', 'Diagnostic Test: serum albumin']}], 'interventions': [{'name': 'complete blood count', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood test', 'armGroupLabels': ['case', 'control']}, {'name': 'serum albumin', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood test', 'armGroupLabels': ['case', 'control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hadeer F Mohamed, resident', 'role': 'CONTACT', 'email': 'hadeer.fadl@med.sohag.edu.eg', 'phone': '01030536331'}, {'name': 'osama S Daifallah, AssistantProf', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at rheumatology and rehabilitation department at sohag university hospitals', 'investigatorFullName': 'Hadeer Fadlalmawla Mohamed', 'investigatorAffiliation': 'Sohag University'}}}}