Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT04663451
Status:
UNKNOWN
Last Update Posted:
2021-04-19
First Post:
2020-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Assessment of the Occurrence of Hypothyroidism in Patients Treated With RAI for Hyperthyroidism.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2020-11-26', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients in which hypothyroidism occurs', 'timeFrame': 'Within 1 year after treatment', 'description': 'The proportion of patients in which hypothyroidism occurs after radioiodine treatment'}, {'measure': 'The proportion of patients in which hypothyroidism occurs', 'timeFrame': 'Between 1-2 years after treatment', 'description': 'The proportion of patients in which hypothyroidism occurs after radioiodine treatment'}, {'measure': 'The proportion of patients in which hypothyroidism occurs', 'timeFrame': 'Between 2-5 years after treatment', 'description': 'The proportion of patients in which hypothyroidism occurs after radioiodine treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nodule Solitary Thyroid', 'Toxic Multinodular Goiter', 'Radioactive Iodine-Induced Hypothyroidism']}, 'descriptionModule': {'briefSummary': 'Low RAIU in patients with hyperthyroidism represents a common obstacle in the treatment with RAI. Therefore, a higher dose of RAI must be administered to cure hyperthyroidism in these patients. If we treat patients with thiamazole before starting RAI treatment, serum TSH will rise and result in an increase in iodine uptake by the thyroid gland. By doing so, the dose of RAI to be administered might be lowered to achieve similar therapeutic efficacy.\n\nIn the past, either calculated or fixed doses of 131I have been used to treat hyperthyroidism. The supposed advantage of a calculated dose compared to a fixed dose is the lowering of hypothyroidism frequency. However, various research papers have contradicted this statement.\n\nAntithyroid drugs and RAI therapy have been widely used in the past, either in combination, or independent from one another. This has been done primarily in older patients, to reduce the risk of exacerbation of hyperthyroid symptoms after initiation of RAI.\n\nThe use of propylthiouracil has been shown to decrease the response rate after RAI due to radioprotective effects.\n\nThe use of methimazole and carbimazole did not have a negative effect on treatment failure, as long as the medication was discontinued various days before RAI administration. Although this statement is contested in other studies.\n\nIt is interesting to evaluate retrospective data of patients treated with RAI to evaluate prognostic factors of treatment respons and post RAI hypothyroidism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hyperthyroid patients, either subclinical or overt, who have undergone RAI treatment in the time period of 2005-2015. They have underlying toxic multinodular goiter or a toxic nodule.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hyperthyroid patients, either subclinical or overt, who have undergone RAI treatment in the period of 2005-2015.\n\nExclusion Criteria:\n\n* Prior use of L-thyroxine\n* Prior thyroid surgery\n* Prior RAI treatment\n* Patients with thyroiditis'}, 'identificationModule': {'nctId': 'NCT04663451', 'briefTitle': 'An Assessment of the Occurrence of Hypothyroidism in Patients Treated With RAI for Hyperthyroidism.', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': "An Assessment of the Occurrence of Hypothyroidism in Patients Treated With RAI For Hyperthyroidism, And it's Prognostic Factors.", 'orgStudyIdInfo': {'id': '2019/435'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Toxic Nodule', 'description': 'Hyperthyroid patients with underlying toxic nodule', 'interventionNames': ['Radiation: radioacive iodine therapy']}, {'label': 'Toxic multinodular goiter', 'description': 'Hyperthyroid patients with underlying toxic multinodular goiter', 'interventionNames': ['Radiation: radioacive iodine therapy']}], 'interventions': [{'name': 'radioacive iodine therapy', 'type': 'RADIATION', 'description': 'Hyperthyroid patients who have undergone radioactive iodine treatment to cure them from their hyperthyroidism.', 'armGroupLabels': ['Toxic Nodule', 'Toxic multinodular goiter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Corina Andreescu, Doctorate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data may be shared with other researchers to continue this type of research in this particular domain and to answer further questions that arise from the process of this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the department of Internal Medicine and Endocrinology', 'investigatorFullName': 'Brigitte Velkeniers', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}