Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT06029335
Status:
UNKNOWN
Last Update Posted:
2023-09-11
First Post:
2023-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Investigations of serum samples for biomarkers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2023-08-31', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini-mental State Examination', 'timeFrame': '12 months', 'description': 'Complex Cognitive measure'}, {'measure': 'The Functional Assessment of Chronic Illness Therapy F', 'timeFrame': '12 months', 'description': 'health-related quality of life measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Sclerosis', 'Systemic Lupus Erythematosus', 'Myopathies, Inflammatory', 'Rheumatoid Arthritis', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '32293528', 'type': 'BACKGROUND', 'citation': 'Olah C, Schwartz N, Denton C, Kardos Z, Putterman C, Szekanecz Z. Cognitive dysfunction in autoimmune rheumatic diseases. Arthritis Res Ther. 2020 Apr 15;22(1):78. doi: 10.1186/s13075-020-02180-5.'}, {'pmid': '40757427', 'type': 'DERIVED', 'citation': 'Krampek L, Kiss F, Farkas N, Faludi R, Nagy G, Szabo A, Czirjak L, Varju C. Risk factors of cognitive function impairment in patients with systemic sclerosis. Clin Exp Rheumatol. 2025 Aug;43(8):1481-1491. doi: 10.55563/clinexprheumatol/isx6h8. Epub 2025 Aug 1.'}]}, 'descriptionModule': {'briefSummary': "Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical, including the central nervous system. Formerly published investigations emphasize a mild cognitive impairment affecting attention, memory, and complicated solution tasks. However, these symptoms significantly impact patients' routines and quality of life. The study examined the associations between cognitive impairment and clinical parameters regarding systemic autoimmune diseases.\n\nMethods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF, Galectin-3, and Pentraxin as well as results of functional, quality of life, and neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients were enrolled into the study originating from the Rheumatology and Immunology Department, Medical School, University of Pécs.\n\nControl healthy groups including consecutive sex and age-matched healthy individuals are invited to participate.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemic autoimmune diseases\n* Healthy individuals - as controls\n\nExclusion Criteria:\n\n* Diseases of the central nervous system\n* Presence of pregnancy'}, 'identificationModule': {'nctId': 'NCT06029335', 'briefTitle': 'Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases', 'orgStudyIdInfo': {'id': '35147-3/2020/ EÜIG'}, 'secondaryIdInfos': [{'id': '05570-6/2023', 'type': 'OTHER', 'domain': 'National Public Health Centre Institutional Committee of Science and Research Ethics Hungary'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diffuse cutaneous Systemic sclerosis', 'description': 'Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.'}, {'label': 'Limited cutaneous Systemic sclerosis', 'description': 'Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.'}, {'label': "Primary Raynaud's", 'description': 'Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.'}, {'label': 'Healthy', 'description': 'Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.'}, {'label': 'Rheumatoid arthritis', 'description': 'Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.'}, {'label': 'Inflammatory myopathies', 'description': 'Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.'}, {'label': 'Systemic lupus erythematosus', 'description': 'Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7632', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'University of Pécs, Department of Rheumatology and Immunology', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data are not publicly available due to ethical issues.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'dr Varjú Cecília', 'investigatorAffiliation': 'University of Pecs'}}}}