Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT05914532
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2023-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Biomarkers in Axial Sypondyloarthropathy; SII and SIRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2023-06-10', 'studyFirstSubmitQcDate': '2023-06-21', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of SIRI and SII between Patient and Healthy Control', 'timeFrame': 'Baseline', 'description': 'SIRI= neutrophil count\\*monocyte count/lymphocyte count and SII= neutrophil count\\*platelet count/lymphocyte count.'}], 'secondaryOutcomes': [{'measure': 'Correlation analysis of SIRI and SII with scales and laboratory findings', 'timeFrame': 'Baseline', 'description': 'SIRI= neutrophil count\\*monocyte count/lymphocyte count and SII= neutrophil count\\*platelet count/lymphocyte count.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Axial Spondyloarthritis', 'Systemic Immune Inflammation Index', 'Systemic Inflammation Response Index'], 'conditions': ['Axial Spondyloarthritis']}, 'referencesModule': {'references': [{'pmid': '34418163', 'type': 'BACKGROUND', 'citation': 'Wu J, Yan L, Chai K. Systemic immune-inflammation index is associated with disease activity in patients with ankylosing spondylitis. J Clin Lab Anal. 2021 Sep;35(9):e23964. doi: 10.1002/jcla.23964. Epub 2021 Aug 21.'}]}, 'descriptionModule': {'briefSummary': 'investigators aimed to evaluate the relationship between Systemic Immune Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) and disease activity in patients with axial spondyloarthropathy (SpA).', 'detailedDescription': 'The clinical characteristics and laboratory data of the patients and healthy controls participating in our study were obtained through the hospital system. Then, the new biomarkers SIRI and SII values were calculated. SIRI= neutrophil count\\*monocyte count/lymphocyte count and SII= neutrophil count\\*platelet count/lymphocyte count. Then, SIRI and SII values were compared between groups. The relationship between disease activity and SIRI and SII values in the patient group was examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1:healthy controls working in our hospital,\n\nGroup 2: SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria\n* 51 healthy controls working in our hospital,\n\nExclusion Criteria:\n\ninfections, coronary artery disease, kidney and liver dysfunction, cancer diagnosis, surgery in the last three months, diabetes mellitus diagnosis, hypertension and pregnant women'}, 'identificationModule': {'nctId': 'NCT05914532', 'briefTitle': 'New Biomarkers in Axial Sypondyloarthropathy; SII and SIRI', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Training and Research Hospital'}, 'officialTitle': 'In Patients With Axial Spondyloarthropathy; Evaluation of the Relationship Between the Systemic Immune Inflammation Index and the Systemic Inflammatory Response Index With Disease Activity and Function', 'orgStudyIdInfo': {'id': '19/08/2022, 2011-KAEK-50: 262'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'healthy controls', 'interventionNames': ['Other: lab testing']}, {'label': 'group 2', 'description': 'axial spondyloarthropathy', 'interventionNames': ['Other: lab testing']}], 'interventions': [{'name': 'lab testing', 'type': 'OTHER', 'description': 'Complete blood count and erythrocyte sedimentation rate and C-reactive protein values of the participants were analyzed by laboratory test.', 'armGroupLabels': ['group 1', 'group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Training and Resarch Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Burak Tayyip DEDE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İstanbul Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Medicine and Rehabilitation', 'investigatorFullName': 'Burak Tayyip Dede', 'investigatorAffiliation': 'Istanbul Training and Research Hospital'}}}}