Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-26 @ 7:25 AM
Study NCT ID:
NCT07105566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triosephosphate Isomerase Level in Relation to Rheumatoid Aerthritis Activity and Structural Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-08-02', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Triosephosphate Isomerase (TPI) concentration (ng/mL) in Rheumatoid Arthritis (RA) patients', 'timeFrame': 'baseline', 'description': 'This outcome assesses the quantitative difference in serum TPI concentrations, measured in nanograms per milliliter (ng/mL), between patients diagnosed with Rheumatoid Arthritis and age- and sex-matched healthy individuals.'}], 'secondaryOutcomes': [{'measure': 'Correlation of serum TPI with Rheumatoid Arthritis disease activity markers', 'timeFrame': 'baseline', 'description': 'This outcome assesses the association between serum TPI levels (ng/mL) and established disease activity markers in RA patients, specifically Disease Activity Score in 28 joints with ESR (DAS28-ESR)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '29417936', 'type': 'BACKGROUND', 'citation': 'Smolen JS, Aletaha D, Barton A, Burmester GR, Emery P, Firestein GS, Kavanaugh A, McInnes IB, Solomon DH, Strand V, Yamamoto K. Rheumatoid arthritis. Nat Rev Dis Primers. 2018 Feb 8;4:18001. doi: 10.1038/nrdp.2018.1.'}, {'pmid': '34899740', 'type': 'BACKGROUND', 'citation': 'Zuo J, Tang J, Lu M, Zhou Z, Li Y, Tian H, Liu E, Gao B, Liu T, Shao P. Glycolysis Rate-Limiting Enzymes: Novel Potential Regulators of Rheumatoid Arthritis Pathogenesis. Front Immunol. 2021 Nov 24;12:779787. doi: 10.3389/fimmu.2021.779787. eCollection 2021.'}, {'pmid': '37527020', 'type': 'BACKGROUND', 'citation': 'Escal J, Neel T, Hodin S, Boussoualim K, Amouzougan A, Coassy A, Locrelle H, Thomas T, Delavenne X, Marotte H. Proteomics analyses of human plasma reveal triosephosphate isomerase as a potential blood marker of methotrexate resistance in rheumatoid arthritis. Rheumatology (Oxford). 2024 May 2;63(5):1368-1376. doi: 10.1093/rheumatology/kead390.'}, {'pmid': '20872595', 'type': 'BACKGROUND', 'citation': 'Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.'}, {'pmid': '29464524', 'type': 'BACKGROUND', 'citation': 'Medina YF, Ruiz-Gaviria RE, Buitrago-Lopez A, Villota C. Physical articular examination in the activity of rheumatoid arthritis: a systematic review of the literature : Systematic review of the literature regarding physical examination in rheumatoid arthritis. Clin Rheumatol. 2018 Jun;37(6):1457-1464. doi: 10.1007/s10067-018-4015-4. Epub 2018 Feb 20.'}]}, 'descriptionModule': {'briefSummary': '1. Assess the serum level of TPI in patients with RA compared to healthy controls.\n2. Correlate serum level of TPI and disease activity.\n3. Correlation of serum TPI level with US7 damage index', 'detailedDescription': "Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by persistent synovial inflammation, synovial hyperplasia, and progressive destruction of bone and cartilage. These pathological processes can lead to joint deformities and loss of function, significantly affecting patients' quality of life. In addition to joint damage, RA often manifests with extraarticular complications involving the cardiovascular, pulmonary, and other organ systems. These systemic effects impose a substantial burden on patients' physical and mental well-being, as well as their socioeconomic status .The disease often affects subjects between the ages of 40 and 70; however, it can also occur at a younger age. Globally, the prevalence rate of RA is approximately 1%, with females experiencing a higher incidence . Triosephosphate isomerase (TPI) is a metabolic enzyme that regulates the flow of glycolysis and energy generation by converting dihydroxyacetone phosphate (DHAP) into D- glyceraldehyde 3-phosphate (G3P). TPI is one of the glycolytic enzymes implicated in the pathogenesis of RA.\n\nAdditionally, it has been shown to possess functions beyond glycolysis, including potential roles in the nucleus related to cancer pathogenesis and chemotherapy resistance . Some studies showed a significant correlation between elevated TPI levels and RA, with TPI serving as an independent predictor of the disease. With some findings, which include a high sensitivity of 98.5% and specificity of 100%, suggest that TPI could be a valuable biomarker for the early diagnosis and management of RA"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult RA patients and age- and sex-matched healthy controls will be included', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adult patients with RA who fulfill 2010 ACR/EULAR classification criteria\n\nExclusion Criteria:\n\n1. Individuals with uncontrolled chronic diseases such as hypertension , diabetes, heart disease, liver or kidney disease, other autoimmune disorders and tumors.\n2. Pregnant women.\n3. Rheumatologic diseases other than RA'}, 'identificationModule': {'nctId': 'NCT07105566', 'briefTitle': 'Triosephosphate Isomerase Level in Relation to Rheumatoid Aerthritis Activity and Structural Damage', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Serum Triosephosphate Isomerase Level in Pateints With Rheumatoid Arthritis : Relation to Disease Activity and Structural Damage', 'orgStudyIdInfo': {'id': 'TPI level in RA patients'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases', 'description': 'Rheumatoid Arthritis pateints', 'interventionNames': ['Diagnostic Test: serum TPI']}, {'label': 'controls', 'description': 'healthy controls', 'interventionNames': ['Diagnostic Test: serum TPI']}], 'interventions': [{'name': 'serum TPI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['ultrasound'], 'description': 'serum TPI level', 'armGroupLabels': ['cases', 'controls']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nada Mohsen', 'role': 'CONTACT', 'email': 'nadamohsen702@gmail.com', 'phone': '01020930427'}], 'overallOfficials': [{'name': 'Safaa Mahran, proff', 'role': 'STUDY_DIRECTOR', 'affiliation': 'World Health Organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nada Mohsen Obeid Hassan', 'investigatorAffiliation': 'Assiut University'}}}}