Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT07149402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association of Serum Interleukin-33 Levels With Clinical Manifestations in Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum IL-33 levels', 'timeFrame': 'Baseline', 'description': 'Quantification of serum IL-33 concentrations using a high-sensitivity ELISA kit across three groups: healthy controls, SLE patients without nephritis, and SLE patients with nephritis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SLE', 'IL-33'], 'conditions': ['SLE']}, 'referencesModule': {'references': [{'pmid': '29247993', 'type': 'BACKGROUND', 'citation': 'Cayrol C, Girard JP. Interleukin-33 (IL-33): A nuclear cytokine from the IL-1 family. Immunol Rev. 2018 Jan;281(1):154-168. doi: 10.1111/imr.12619.'}]}, 'descriptionModule': {'briefSummary': "This is a case-control study investigating serum IL-33 levels and their association with clinical manifestations in systemic lupus erythematosus (SLE). The study compares IL-33 levels in three groups: SLE patients with lupus nephritis, SLE patients without nephritis, and healthy controls. The goal is to clarify IL-33's role as a biomarker reflecting disease activity and organ involvement, especially renal pathology.", 'detailedDescription': "Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with variable clinical presentations, ranging from mild symptoms to life-threatening organ damage. Lupus nephritis, a severe renal manifestation of SLE, significantly contributes to morbidity and mortality. IL-33, a cytokine from the IL-1 family, has been implicated in immune regulation and inflammation, emerging as a potential marker in SLE pathogenesis and progression.\n\nThis study systematically evaluates serum IL-33 levels in 96 participants divided into three groups: SLE patients with lupus nephritis, SLE patients without nephritis, and matched healthy controls. The study is conducted over one year at the Rheumatology Department of Assiut University Hospital. It includes clinical assessments, laboratory investigations (including ELISA for IL-33, autoantibody profiles, renal function), renal Doppler ultrasound for nephritis patients, and renal biopsy analyzed using ISN/RPS classification.\n\nBy assessing IL-33 levels alongside clinical manifestations, disease activity indices, and histopathological findings, the study aims to define IL-33's diagnostic and prognostic utility in lupus nephritis and overall SLE disease monitoring. Statistical analysis with SPSS includes ANOVA and correlation tests to detect differences and associations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population includes three groups, each with 32 participants for a total of 96 individuals. Inclusion criteria for SLE patients consist of adults aged 18 to 65 years diagnosed per ACR criteria. The lupus nephritis group includes patients with biopsy-confirmed nephritis. Healthy controls are age- and sex-matched individuals without autoimmune or renal diseases.\n\nExclusion criteria contain coexisting autoimmune diseases, chronic infections, malignancies, pregnancy or lactation, end-stage renal disease or dialysis, and those declining consent. This carefully selected population ensures reliable comparisons of IL-33 levels relative to clinical and pathological traits. The sample size was powered to detect medium effect size differences in IL-33 levels among the three groups.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Diagnosed with systemic lupus erythematosus according to the American College of Rheumatology (ACR) criteria.\n* For the lupus nephritis group: confirmed diagnosis of lupus nephritis based on clinical, laboratory, and renal biopsy findings.\n* For the control group: healthy individuals matched for age and sex, with no history of autoimmune or renal diseases.\n\nExclusion Criteria:\n\n* Patients with other autoimmune diseases. Patients with chronic infections or malignancies. Pregnant or lactating women. Patients with end-stage renal disease (ESRD) or on dialysis. Individuals who refuse to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07149402', 'briefTitle': 'Association of Serum Interleukin-33 Levels With Clinical Manifestations in Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Serum Interleukin-33 (IL-33) Levels and Their Association With Clinical Manifestations in Patients With Systemic Lupus Erythematosus and Lupus Nephritis at Assiut University Hospital', 'orgStudyIdInfo': {'id': 'SLE Interleukin-33 Levels'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SLE without Nephritis', 'description': 'Patients diagnosed with systemic lupus erythematosus but without evidence of renal involvement. Clinical and laboratory data are collected to correlate IL-33 levels with disease activity excluding renal manifestations.'}, {'label': 'SLE with Lupus Nephritis', 'description': 'Patients with systemic lupus erythematosus and confirmed lupus nephritis via biopsy and clinical parameters. This group undergoes detailed renal Doppler imaging and biopsy assessment to evaluate the relationship of IL-33 with renal involvement.'}, {'label': 'Healthy Controls', 'description': 'Age- and sex-matched healthy individuals without autoimmune or renal disease, serving as baseline comparators for IL-33 serum levels and immune profiles.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at the Rheumatology Department', 'investigatorFullName': 'Marly Mamdouh', 'investigatorAffiliation': 'Assiut University'}}}}