Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
Study NCT ID:
NCT06585592
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2024-08-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishment of Multimodal-multiparametric Progressive Prediction Models for Thyroid Associated Ophthalmopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2024-08-29', 'studyFirstSubmitQcDate': '2024-09-02', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of extraocular muscle volume and orbital fat volume by MR', 'timeFrame': '52 weeks after the end of treatment'}, {'measure': 'change of extraocular muscle volume and orbital fat volume by MRI', 'timeFrame': '4 weeks after the end of treatment'}, {'measure': 'change of extraocular muscle volume and orbital fat volume by MRI', 'timeFrame': '24 weeks after the end of treatment'}], 'primaryOutcomes': [{'measure': 'Percentage of participants with overall response', 'timeFrame': '1 week after the end of treatment', 'description': 'Overall response'}, {'measure': 'Percentage of participants with overall response', 'timeFrame': '24 weeks after the end of treatment', 'description': 'Overall response'}, {'measure': 'Percentage of participants with overall response', 'timeFrame': '52 weeks after the end of treatment', 'description': 'Overall response'}, {'measure': 'Percentage of participants with overall response', 'timeFrame': '104 weeks after the end of treatment', 'description': 'Overall response'}], 'secondaryOutcomes': [{'measure': 'Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) during the treament', 'timeFrame': 'during the treament'}, {'measure': 'Change of Serum TRAb from baseline', 'timeFrame': '52 weeks after the end of treatment', 'description': 'including TRAb (IU/l)'}, {'measure': 'Change of Serum T3,T4 level from baseline', 'timeFrame': '52 weeks after the end of treatment', 'description': 'inculde T3 (nmol/L), T4 (nmol/L)'}, {'measure': 'Change of Serum lipid parameter', 'timeFrame': '52 weeks after the end of treatment', 'description': 'including TG (mmol/L), TC (mmol/L), HDL (mmol/L), LDL (mmol/L)'}, {'measure': 'Change of Serum TSH level from baseline', 'timeFrame': '52 weeks after the end of treatment', 'description': 'including TSH (mIU/L)'}, {'measure': 'Change of Serum FT3, FT4 level from baseline', 'timeFrame': '104 weeks after the end of treatment', 'description': 'including FT3 (pmol/L), FT4(pmol/L)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid-Associated Ophthalmopathy']}, 'referencesModule': {'references': [{'pmid': '34252869', 'type': 'BACKGROUND', 'citation': 'Zhai L, Luo B, Wu H, Wang Q, Yuan G, Liu P, Ma Y, Zhao Y, Zhang J. Prediction of treatment response to intravenous glucocorticoid in patients with thyroid-associated ophthalmopathy using T2 mapping and T2 IDEAL. Eur J Radiol. 2021 Sep;142:109839. doi: 10.1016/j.ejrad.2021.109839. Epub 2021 Jul 3.'}, {'pmid': '36780178', 'type': 'BACKGROUND', 'citation': "Li Z, Luo Y, Feng X, Zhang Q, Zhong Q, Weng C, Chen Z, Shen J. Application of Multiparameter Quantitative Magnetic Resonance Imaging in the Evaluation of Graves' Ophthalmopathy. J Magn Reson Imaging. 2023 Oct;58(4):1279-1289. doi: 10.1002/jmri.28642. Epub 2023 Feb 13."}, {'pmid': '35092642', 'type': 'BACKGROUND', 'citation': 'Hu H, Chen L, Zhang JL, Chen W, Chen HH, Liu H, Shi HB, Wu FY, Xu XQ. T2 -Weighted MR Imaging-Derived Radiomics for Pretreatment Determination of Therapeutic Response to Glucocorticoid in Patients With Thyroid-Associated Ophthalmopathy: Comparison With Semiquantitative Evaluation. J Magn Reson Imaging. 2022 Sep;56(3):862-872. doi: 10.1002/jmri.28088. Epub 2022 Jan 29.'}]}, 'descriptionModule': {'briefSummary': 'Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.\n\nThe aim of this clinical study is to:\n\n1. Found characteristic changes from baseline to the end of treatment.\n2. Identify characteristic changes associated with treatment response.\n3. Construct a multimodal and multiparameter prediction model by characteristic changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Moderate to severe active TAO patients who received complete medical treatment and completed assessment .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* According to the Bartley criteria，diagnosed TAO from 2017/1/1 to 2024/3/31\n* Moderate to severe patients defined by EUGOGO\n* CAS ≥4 (on the 7-item scale) for the study eye\n* Completed orbital MRI at our hospital\n* Received complete medical treatment and completed assessment at our hospital\n\nExclusion Criteria:\n\n* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision\n* History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to \\< 1 g of methylprednisolone for the treatment of TAO.\n* Any major illness/condition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study\n* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation in the study\n* Pregnant or lactating\n* Any other condition that,would impair the ability of the participant to undergo orbital MRI'}, 'identificationModule': {'nctId': 'NCT06585592', 'briefTitle': 'Establishment of Multimodal-multiparametric Progressive Prediction Models for Thyroid Associated Ophthalmopathy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'Establishment of Multimodal-multiparametric Progressive Prediction Models for Thyroid Associated Ophthalmopathy', 'orgStudyIdInfo': {'id': 'TAO3M-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director', 'investigatorFullName': 'Tuo Li, MD', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}