Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 3:07 AM
Study NCT ID:
NCT07480720
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes in Graves Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-14', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripapillary Retinal Nerve Fiber Layer Thickness', 'timeFrame': 'Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026', 'description': 'Evaluation and comparison of peripapillary retinal nerve fiber layer thickness values in different quadrants among study groups.'}, {'measure': 'Macular Thickness Measured by Optical Coherence Tomography', 'timeFrame': 'Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026', 'description': 'Comparison of macular thickness measurements among healthy controls, Graves disease patients without ophthalmopathy, and Graves disease patients with ophthalmopathy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Graves disease', 'Thyroid autoimmunity', 'Systemic inflammation', 'Optical coherence tomography', 'Retinal nerve fiber layer', 'Graves ophthalmopathy'], 'conditions': ['Graves Disease', 'Graves Ophthalmopathy']}, 'descriptionModule': {'briefSummary': 'This retrospective observational study aims to evaluate the relationship between systemic inflammatory parameters, thyroid autoimmunity markers, and neuroretinal structures in patients with Graves disease. Medical records of patients diagnosed with Graves disease and healthy control subjects evaluated at Elazığ Fethi Sekin City Hospital between August 2018 and January 2026 will be reviewed. Optical coherence tomography (OCT) measurements, including macular thickness and peripapillary retinal nerve fiber layer (RNFL) thickness, will be analyzed. Laboratory parameters such as complete blood count-derived inflammatory indices, C-reactive protein, thyroid function tests, and thyroid autoantibodies will also be recorded. The study will compare neuroretinal parameters between healthy controls, Graves disease patients without ophthalmopathy, and Graves disease patients with ophthalmopathy, and will investigate potential associations between systemic inflammation, thyroid autoimmunity, and neuroretinal structural changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population will consist of adult patients diagnosed with Graves' disease who are followed in the endocrinology and ophthalmology clinics of the participating institution. Patients who meet the inclusion criteria and have available optical coherence tomography (OCT) measurements and laboratory data will be included in the patient group.\n\nThe control group will consist of age- and sex-matched healthy volunteers without a history of thyroid disease or ocular pathology, recruited from individuals undergoing routine ophthalmologic examination.\n\nAll participants will be evaluated for neuroretinal structural parameters using OCT and systemic inflammatory markers obtained from laboratory tests.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n\nDiagnosis of Graves' disease (for the patient group)\n\nNo known thyroid disease in healthy control participants\n\nAvailability of optical coherence tomography (OCT) measurements and laboratory data\n\nTime interval between OCT examination and blood sampling ≤ 10 days\n\nExclusion Criteria:\n\n* Presence of glaucoma, optic neuropathy, or retinal vascular diseases\n\nMacular diseases, uveitis, or severe refractive error (high myopia \\>6 diopters)\n\nDiabetic retinopathy\n\nHistory of previous intraocular surgery\n\nHistory of active infection, malignancy, or systemic inflammatory disease\n\nPoor-quality OCT measurements (segmentation errors or low signal strength)"}, 'identificationModule': {'nctId': 'NCT07480720', 'briefTitle': 'Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes in Graves Disease', 'organization': {'class': 'OTHER', 'fullName': 'Elazıg Fethi Sekin Sehir Hastanesi'}, 'officialTitle': 'Relationship Between Systemic Inflammation, Thyroid Autoimmunity, and Neuroretinal Structures in Graves Disease', 'orgStudyIdInfo': {'id': 'FSCH-2026-24-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Controls', 'description': 'Age-matched healthy individuals without known thyroid disease or autoimmune disorders who underwent ophthalmologic examination and optical coherence tomography evaluation.'}, {'label': 'Graves Disease Without Ophthalmopathy', 'description': 'Patients diagnosed with Graves disease who do not have clinical signs of Graves ophthalmopathy and who underwent optical coherence tomography evaluation.'}, {'label': 'Graves Disease With Ophthalmopathy', 'description': 'Patients diagnosed with Graves disease who have clinical findings consistent with Graves ophthalmopathy and who underwent optical coherence tomography evaluation.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Elâzığ', 'state': 'Elaziğ', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'SİNEM KESER, MD', 'role': 'CONTACT', 'email': 'kesersinem@hotmail.com', 'phone': '+905070646384'}], 'facility': 'Fethi Sekin City Hospital', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}], 'centralContacts': [{'name': 'SİNEM KESER, MD', 'role': 'CONTACT', 'email': 'kesersinem@hotmail.com', 'phone': '+905070646384'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elazıg Fethi Sekin Sehir Hastanesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sinem Keser', 'investigatorAffiliation': 'Elazıg Fethi Sekin Sehir Hastanesi'}}}}