Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 5:52 PM
Study NCT ID:
NCT06796569
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Immune Inflammatory Index in Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'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'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'association of systemic immune-inflammation index (SII) disease activity in systemic lupus erythematosus', 'timeFrame': 'baseline', 'description': 'This study aims to investigate if there is an association between the systemic immune-inflammation index (SII) and disease activity in patients with systemic lupus erythematosus using SLEDAI(systemic lupus erythematosus disease activity index) as a valid index to compare results with'}, {'measure': 'association of systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus', 'timeFrame': 'baseline', 'description': 'This study aims to investigate the association between the systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus', 'Lupus Nephritis']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the association between the systemic immune-inflammation index and disease activity, as well as lupus nephritis in patients with systemic lupus erythematosus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients attending in rheumatology outpatient clinic, sohag university hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* o Older than 16 years\n\n * In a patient with SLE, patients who fulfill the criteria of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR).\n * In patients with LN, patients whose diagnosis is confirmed by kidney biopsy and pathohistological verification (WHO classification, and the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification.\n\nExclusion Criteria:\n\n* Patients with other autoimmune rheumatological diseases, lymphoproliferative disorders, malignancies, liver diseases, end-stage kidney disease, diabetic nephropathy, active infections, recent history of blood transfusion and patients with deficiencies in vitamin B12, folate, and iron are excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06796569', 'briefTitle': 'Systemic Immune Inflammatory Index in Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Association of Systemic Immune Inflammatory Index with Disease Activity and Lupus Nephritis in Patients with Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'soh-Med-25-1-2MD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients diagnosed with systemic lupus and lupus nephritis', 'description': 'this group will include 30 patients, all patients will undergo the following: For the evaluation of SLE clinical disease activity SLEDAI ( systemic upus erythematosus disease activity index)scores will be recorded The SII (systemic immune inflammatory index) will be calculatedusing the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.', 'interventionNames': ['Diagnostic Test: systemic immune inflammatory index']}, {'label': 'patients diagnosed with systemic lupus without lupus nephritis', 'description': 'this group will also include 30 patients, all patients will undergo the following: For the evaluation of SLE clinical disease activity SLEDAI ( systemic upus erythematosus disease activity index)scores will be recorded The SII (systemic immune inflammatory index) will be calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.', 'interventionNames': ['Diagnostic Test: systemic immune inflammatory index']}, {'label': 'healthy control group', 'description': 'this group will also include 30 healthy controls , they will undergo the following: The SII (systemic immune inflammatory index) will be calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.', 'interventionNames': ['Diagnostic Test: systemic immune inflammatory index']}], 'interventions': [{'name': 'systemic immune inflammatory index', 'type': 'DIAGNOSTIC_TEST', 'description': 'Systemic immune inflammatory index (SII) is a combination of three hematological parameters (platelets, neutrophils, and lymphocytes) and it is calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.', 'armGroupLabels': ['healthy control group', 'patients diagnosed with systemic lupus and lupus nephritis', 'patients diagnosed with systemic lupus without lupus nephritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1670005', 'city': 'Sohag', 'state': 'Sohag Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Shorouk Mohamed abdelmageed, master degree', 'role': 'CONTACT', 'email': 'Shrouk011107@med.sohag.edu.eg', 'phone': '02+01099082079'}], 'facility': 'Sohag Faculty', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Shorouk Mohamed abdelmageed, master degree', 'role': 'CONTACT', 'email': 'Shrouk011107@med.sohag.edu.eg', 'phone': '02 +01099082079'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Shorouk Ayman Mohamed', 'investigatorAffiliation': 'Sohag University'}}}}