Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT07149194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accuracy of CBC Derived Markers Against CRP and ESR in Detecting Active Rheumatoid Arthritis in Upper Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2025-08-24', 'studyFirstSubmitQcDate': '2025-08-24', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the diagnostic accuracy of CBC-derived inflammatory markers in detecting active rheumatoid arthritis in Upper Egypt.', 'timeFrame': 'baseline', 'description': 'the accuracy of CBC-derived inflammatory markers in diagnosis of active rheumatoid arthritis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatic Diseases']}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis (RA) is a chronic autoimmune disease that leads to persistent synovial inflammation, joint destruction, and disability, often with extra-articular manifestations like interstitial pneumonia. It predominantly affects middle-aged individuals, especially women. Early diagnosis and accurate disease activity assessment are crucial to prevent irreversible joint damage and systemic complications (4).\n\nClinical tools like the Disease Activity Score in 28 joints (DAS28) are commonly used to monitor RA, relying on inflammatory markers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). However, CRP and ESR can be influenced by factors unrelated to RA, such as infections or anemia, and may not always be available or cost-effective in resource-limited settings (1).\n\nIn recent years, complete blood count (CBC)-derived markers have emerged as affordable and accessible alternatives for assessing systemic inflammation. These include the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and red cell distribution width (RDW). These indices have shown strong correlations with RA disease activity in various studies, particularly NLR and RDW, which have high sensitivity and specificity for detecting active disease (2-3).\n\nStudies in Egypt have explored the diagnostic accuracy of CBC-derived markers and composite indices like the CRP-to-albumin ratio (CAR) and albumin-to-fibrinogen ratio (AFR). These markers correlate significantly with DAS28 scores, suggesting they may be reliable indicators of RA disease activity in Egyptian patients (1-3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-Adults aged ≥18 years. 2-Established RA diagnosis according to ACR/EULAR criteria {ACR: American College of Rheumatology, a professional organization of rheumatologists.\n\nEULAR: European League Against Rheumatism, a European organization for rheumatology.\n\n3-Willing to provide informed consent\n\nExclusion Criteria:\n\n* 1-Presence of infection, malignancy, or other autoimmune diseases. 2-Recent use (within 4 weeks) of corticosteroids or immunosuppressive therapy. 3-Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT07149194', 'briefTitle': 'Accuracy of CBC Derived Markers Against CRP and ESR in Detecting Active Rheumatoid Arthritis in Upper Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of the Accuracy of CBC-Derived Markers Against CRP and ESR in Detecting Active Rheumatoid Arthritis in Upper Egypt"', 'orgStudyIdInfo': {'id': 'CBC markers in RA activity'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active Rheumatoid arthritis', 'interventionNames': ['Other: CBC derived markers']}, {'label': 'inactive Rheumatoid arthriti'}], 'interventions': [{'name': 'CBC derived markers', 'type': 'OTHER', 'description': 'CBC derived markers against CRP and ESR in detecting active Rheumatoid arthritis', 'armGroupLabels': ['Active Rheumatoid arthritis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abeer Hamdi Fahmi', 'role': 'CONTACT', 'email': 'abeerhamdi69@gmail.com', 'phone': '01115332487'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assessment of accuracy of CBC derived markers against CRP and ESR in detecting active Rheumatoid arthritis in upper Egypt', 'investigatorFullName': 'Abeer Hamdi Fahmi Abd Elhamid', 'investigatorAffiliation': 'Assiut University'}}}}