Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-13 @ 6:54 PM
Study NCT ID:
NCT06521359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-25
First Post:
2024-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Follicular T Cells in Hashimoto's Thyroiditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050031', 'term': 'Hashimoto Disease'}], 'ancestors': [{'id': 'D013967', 'term': 'Thyroiditis, Autoimmune'}, {'id': 'D013966', 'term': 'Thyroiditis'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005434', 'term': 'Flow Cytometry'}], 'ancestors': [{'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Measure the frequency of Follicular helper Tcells and Follicular regulatory T cells in peripheral blood samples in Hashimoto's pts in comparison with control.", 'timeFrame': 'Baseline', 'description': "Measure changes in number of surface markers CD4 , ICOS, CXCR5 and FOXP3. Follicular helper Tcells and Follicular regulatory T cells in peripheral blood samples in Hashimoto's pts in comparison with control."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Hashimoto's Thyroiditis"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/books/NBK459262/', 'label': 'Mincer DL, Jialal I. Hashimoto Thyroiditis. \\[Updated 2023 Jul 29\\]. In: StatPearls \\[Internet\\]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-'}]}, 'descriptionModule': {'briefSummary': "Measure the frequency of Follicular helper Tcells and Follicular regulatory T cells in peripheral blood samples in Hashimoto's pts in comparison with control.", 'detailedDescription': 'Hashimoto thyroiditis, also known as chronic autoimmune thyroiditis and chronic lymphocytic thyroiditis, is an autoimmune disease in which thyroid cells are destroyed via cell and antibody-mediated immune processes. It is the most common cause of hypothyroidism in developed countries. In contrast, the most common cause of hypothyroidism worldwide is an inadequate dietary intake of iodine. The pathophysiology of Hashimoto thyroiditis involves the formation of antithyroid antibodies that attack the thyroid tissue, causing progressive fibrosis. The diagnosis can be challenging, and consequently, the condition is sometimes not diagnosed until late in the disease process. The most common laboratory findings demonstrate elevated thyroid-stimulating hormone (TSH) and low thyroxine (T4) levels, coupled with increased antithyroid peroxidase (anti-TPO) antibodies and antithyroglobulin (anti-Tg) antibodies .\n\nRecent years have shown that Hashimoto thyroiditis development depends on an immune defect in an individual with genetic susceptibility together with environmental factors .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study will include 45 Hashimoto's patients attending the out clinics of Endocrinology Department of Assiut university hospital. In addition, 45 healthy blood donors will be included as controls. The diagnosis of hashimoto's thyroiditis will be determined according to the criteria of American Thyroid Association;", 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- The study will include 45 Hashimoto's patients attending the out clinics of Endocrinology Department of Assiut university hospital. In addition, 45 healthy blood donors will be included as controls. The diagnosis of hashimoto's thyroiditis will be determined according to the criteria of American Thyroid Association;\n\n* Having symptoms of hypothyroidism, and a blood test shows an underactive thyroid gland \\[an elevated thyroid stimulating hormone (TSH) level with or without a low thyroid hormone (free T4 or total T4) level\\].\n* have elevated thyroid antibody levels.\n* ultrasound examination demonstrating characteristic heterogeneous echotexture.\n* results of thyroid fine needle aspiration (FNA) examinations meeting HT cytology diagnostic criteria.\n\nExclusion Criteria:\n\n* -We should exclude other causes of thyroiditis, such as De Quervain's thyroiditis, Riedel's thyroiditis, and suppurative thyroiditis and also exclude other autoimmune diseases for example; type1 diabetes\\&Rheumatoid arthritis,and other diseases which cause hypothyroidism as carcinoma and surgery."}, 'identificationModule': {'nctId': 'NCT06521359', 'briefTitle': "Role of Follicular T Cells in Hashimoto's Thyroiditis", 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': "Role of Follicular Helper and Follicular Regulatory T Cells in Hashimoto's Thyroiditis", 'orgStudyIdInfo': {'id': 'flow cytometry in Hashimoto'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'case', 'interventionNames': ['Device: flow cytometry']}, {'label': 'control', 'interventionNames': ['Device: flow cytometry']}], 'interventions': [{'name': 'flow cytometry', 'type': 'DEVICE', 'description': 'Two ml of peripheral venous blood samples will be collected in heparinized tubes from patients and controls for assessment of levels of TFH and TFReg cells by flow cytometry.', 'armGroupLabels': ['case', 'control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Omnia Ahmed Nafea, master', 'role': 'CONTACT', 'email': 'mennanafea97@gmail.com', 'phone': '01125785008'}, {'name': 'Entsar Hamed Ahmed, Professor', 'role': 'CONTACT', 'phone': '01001344841'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Omnia Ahmed Nafea Mohamed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Omnia Ahmed Nafea Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}