Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-07 @ 2:27 AM
Study NCT ID:
NCT07329556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Autofluorescence Assessment of Advanced Glycation End Products in Rheumatic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D016918', 'term': 'Arthritis, Reactive'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D010505', 'term': 'Familial Mediterranean Fever'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D001170', 'term': 'Arthritis, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2025-12-28', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Autofluorescence-Derived Advanced Glycation End Product Level', 'timeFrame': 'Baseline (single study visit)', 'description': 'Advanced glycation end-product (AGE) accumulation assessed non-invasively by skin autofluorescence measurement using a validated AGE Reader device, expressed in arbitrary units (AU).'}], 'secondaryOutcomes': [{'measure': 'Comparison of AGE Levels Between Rheumatic Disease Subtypes', 'timeFrame': 'Baseline (single study visit)', 'description': 'Comparison of skin autofluorescence-derived advanced glycation end-product (AGE) levels among different rheumatic disease subgroups and healthy controls.'}, {'measure': 'Association Between AGE Levels and Inflammatory Markers', 'timeFrame': 'Baseline', 'description': 'Association between skin autofluorescence-derived AGE levels and systemic inflammatory markers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis (RA', 'Ankylosing Spondylitis', 'Psoriatic Arthritis', 'Reactive Arthritis (ReA)', 'Crystal Arthropathies', 'Connective Tissue Diseases', 'Familial Mediterranean Fever (FMF )']}, 'referencesModule': {'references': [{'pmid': '22168993', 'type': 'RESULT', 'citation': 'de Groot L, Hinkema H, Westra J, Smit AJ, Kallenberg CG, Bijl M, Posthumus MD. Advanced glycation endproducts are increased in rheumatoid arthritis patients with controlled disease. Arthritis Res Ther. 2011;13(6):R205. doi: 10.1186/ar3538. Epub 2011 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'Rheumatic diseases are chronic inflammatory conditions that can lead to long-term tissue damage and increased cardiovascular and metabolic risk. Advanced glycation end products (AGEs) are harmful molecules that accumulate in the body over time and are known to promote inflammation and oxidative stress. Increased AGE burden has been implicated in several chronic diseases; however, its role in rheumatic diseases has not been fully clarified.\n\nThis observational, cross-sectional study aims to evaluate the accumulation of AGEs in patients with various rheumatic diseases compared with healthy individuals. AGE levels will be assessed non-invasively using skin autofluorescence measurements.\n\nBy comparing AGE burden between patients and healthy controls, this study seeks to improve understanding of the potential role of AGEs in the pathophysiology of rheumatic diseases and to explore their usefulness as a non-invasive biomarker in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients aged 18 to 75 years diagnosed with inflammatory rheumatic diseases who are followed at a tertiary rheumatology outpatient clinic, as well as age- and sex-matched healthy volunteers without a history of rheumatic or chronic inflammatory disease. All participants will undergo a single, non-invasive skin autofluorescence measurement to assess advanced glycation end-product (AGE) accumulation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Diagnosis of an inflammatory rheumatic disease (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, connective tissue diseases, Behçet disease, familial Mediterranean fever, or crystal arthropathies), confirmed by a rheumatologist\n* Healthy volunteers without a history of rheumatic or chronic inflammatory disease (for the control group)\n* Ability to undergo non-invasive skin autofluorescence measurement\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Diagnosis of diabetes mellitus (type 1 or type 2)\n* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \\< 60 mL/min/1.73 m²\n* Active malignancy or history of malignancy within the past 5 years\n* Presence of acute infection or acute inflammatory condition at the time of assessment\n* Secondary causes of systemic inflammation unrelated to the underlying rheumatic disease (e.g., uncontrolled endocrine disorders, chronic liver disease)\n* Use of medications known to markedly affect AGE accumulation or skin autofluorescence measurements (e.g., recent high-dose systemic glucocorticoids)\n* Pregnancy or breastfeeding\n* Presence of significant skin conditions (e.g., extensive dermatitis, scars, tattoos, or burns) at the measurement site that may interfere with skin autofluorescence assessment\n* Inability to comply with study procedures or to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07329556', 'briefTitle': 'Skin Autofluorescence Assessment of Advanced Glycation End Products in Rheumatic Diseases', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa City Hospital'}, 'officialTitle': 'Evaluation of Advanced Glycation End Products Accumulation in Rheumatic Diseases Using Non-Invasive Skin Autofluorescence Measurements', 'orgStudyIdInfo': {'id': '2026-Rheumatology-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatic Diseases Group', 'description': 'Patients diagnosed with inflammatory rheumatic diseases undergoing skin autofluorescence measurement.'}, {'label': 'Healthy Control Group', 'description': 'Age- and sex-matched healthy volunteers without a diagnosis of rheumatic disease.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Altuğ Güner, MD', 'role': 'CONTACT', 'email': 'altugguner555@gmail.com', 'phone': '+905337414088'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Taner Dandinoğlu', 'investigatorAffiliation': 'Bursa City Hospital'}}}}