Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
Study NCT ID:
NCT06554392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-15
First Post:
2024-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Serum Level of Glutathione Peroxidase 4
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025242', 'term': 'Spondylarthropathies'}], 'ancestors': [{'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-11', 'studyFirstSubmitDate': '2024-08-11', 'studyFirstSubmitQcDate': '2024-08-11', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients.', 'timeFrame': 'baseline', 'description': 'Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients to detect ferroptosis process in those patients.'}], 'secondaryOutcomes': [{'measure': 'The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.', 'timeFrame': 'baseline', 'description': 'The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spondyloarthropathy']}, 'referencesModule': {'references': [{'pmid': '22632970', 'type': 'BACKGROUND', 'citation': 'Dixon SJ, Lemberg KM, Lamprecht MR, Skouta R, Zaitsev EM, Gleason CE, Patel DN, Bauer AJ, Cantley AM, Yang WS, Morrison B 3rd, Stockwell BR. Ferroptosis: an iron-dependent form of nonapoptotic cell death. Cell. 2012 May 25;149(5):1060-72. doi: 10.1016/j.cell.2012.03.042.'}, {'pmid': '31440260', 'type': 'BACKGROUND', 'citation': 'Chen R, Zhu S, Zeng L, Wang Q, Sheng Y, Zhou B, Tang D, Kang R. AGER-Mediated Lipid Peroxidation Drives Caspase-11 Inflammasome Activation in Sepsis. Front Immunol. 2019 Aug 8;10:1904. doi: 10.3389/fimmu.2019.01904. eCollection 2019.'}, {'pmid': '34811833', 'type': 'BACKGROUND', 'citation': 'Yuan S, Wei C, Liu G, Zhang L, Li J, Li L, Cai S, Fang L. Sorafenib attenuates liver fibrosis by triggering hepatic stellate cell ferroptosis via HIF-1alpha/SLC7A11 pathway. Cell Prolif. 2022 Jan;55(1):e13158. doi: 10.1111/cpr.13158. Epub 2021 Nov 22.'}, {'pmid': '30581146', 'type': 'BACKGROUND', 'citation': 'Gao M, Yi J, Zhu J, Minikes AM, Monian P, Thompson CB, Jiang X. Role of Mitochondria in Ferroptosis. Mol Cell. 2019 Jan 17;73(2):354-363.e3. doi: 10.1016/j.molcel.2018.10.042. Epub 2018 Dec 20.'}, {'pmid': '33978684', 'type': 'BACKGROUND', 'citation': 'Chen X, Kang R, Kroemer G, Tang D. Ferroptosis in infection, inflammation, and immunity. J Exp Med. 2021 Jun 7;218(6):e20210518. doi: 10.1084/jem.20210518. Epub 2021 May 12.'}]}, 'descriptionModule': {'briefSummary': '* Analysis of the level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients.\n* The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.', 'detailedDescription': 'Ferroptosis, first reported by Dixon et al. in 2012, is a form of non-apoptotic cell death driven by iron-dependent lipid reactive oxygen species (ROS) and accelerated by the accumulation of lipid peroxides, ultimately leading to oxidative damage to phospholipid membranes and cell death .\n\nFerroptosis could be induced by iron metabolism disorder, lipid peroxidation accumulation, deficiency of glutathione (GSH) and inactivation of the antioxidant enzyme glutathione peroxidase 4 (GPX4).\n\nThe morphological features of ferroptotic cells manifest as an aberrant mitochondrial ultrastructure, including a reduction in mitochondrial volume, an increase in mitochondrial membrane density, and the disappearance of mitochondrial cristae in ferroptotic cells .\n\nRecent studies have increasingly reported on complex associations between ferroptosis and the immune system . The regulatory activity of ferroptosis in immune function and inflammation is multifaceted and involves innate, acquired, and autoimmunity.\n\nAccumulating evidence in recent times has shown an association of ferroptosis with the pathogenesis and development of autoimmune diseases .\n\nSpondyloarthropathy comprises a group of chronic inflammatory rheumatic diseases, including ankylosing spondylitis, reactive arthritis (Reiter syndrome), arthritis or spondylitis associated with inflammatory bowel disease, and psoriatic arthritis, as well as undifferentiated spondyloarthritis. These afflictions predominantly affect the axial skeleton, causing pain and stiffness.\n\nCurrently, research on ferroptosis is still in its early stages; therefore, exploring the pathogenesis of ferroptosis and its role in various diseases, and proposing effective and targeted treatment methods have significant theoretical significance and practical value.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be selected from AS and axial psoriatic arthritis patients presented sequentially at the outpatient clinic and inpatient unit of the Department of Rheumatology, Rehabilitation and Physical Medicine. Faculty of Medicine .Assiut University.in addition to age and sex matched controls.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed as ankylosing spondylitis according to ASAS criteria . \\[13\\]\n* Patients diagnosed as psoriatic arthritis according to CASPAR criteria. \\[14\\]\n* Age (\\>18).\n\nExclusion Criteria:\n\n* Patient with other autoimmune Rheumatic diseases.\n* patients with any of the following conditions: I) severe liver and kidney dysfunction; II) hematopoietic diseases; III) infectious diseases; IV) tumors; or V) other wasting diseases. \\[15\\]\n* patients received certain drugs (for example, sulfasalazine, artemisinin, statins), and experimental reagents (such as erastin) .\\[16\\]'}, 'identificationModule': {'nctId': 'NCT06554392', 'briefTitle': 'Identification of Serum Level of Glutathione Peroxidase 4', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Identification of Glutathione Peroxidase 4 in Detecting Ferroptosis in Ankylosing Spondylitis and Axial Psoriatic Arthritis Patients .', 'orgStudyIdInfo': {'id': 'Glutathione Peroxidase 4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ankylosing Spondylitis patients', 'description': 'Identification of Glutathione Peroxidase 4 in blood.', 'interventionNames': ['Diagnostic Test: Blood sample']}, {'label': 'Axial Psoriatic Arthritis Patients', 'description': 'Identification of Glutathione Peroxidase 4 in blood.', 'interventionNames': ['Diagnostic Test: Blood sample']}, {'label': 'healthy controls', 'description': 'Identification of Glutathione Peroxidase 4 in blood.', 'interventionNames': ['Diagnostic Test: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood sample from each subject to detect Glutathione Peroxidase 4.', 'armGroupLabels': ['Ankylosing Spondylitis patients', 'Axial Psoriatic Arthritis Patients', 'healthy controls']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gehad Fahem, Rd', 'role': 'CONTACT', 'email': 'gehad.16297444@med.aun.edu.eg', 'phone': '+201116770486'}], 'overallOfficials': [{'name': 'Marwa Abdelaziz, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rheumatology,Rehabilition,Physical therapy Department ,Assiut university'}, {'name': 'Marwa Galal, Ass. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rheumatology,Rehabilition,Physical therapy Department ,Assiut university'}, {'name': 'Nesreen Ibrahim, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rheumatology,Rehabilition,Physical therapy Department ,Assiut university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Gehad Abdel Hakeem Abdullah Fahem', 'investigatorAffiliation': 'Assiut University'}}}}