Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT04396158
Status:
UNKNOWN
Last Update Posted:
2020-05-27
First Post:
2020-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'self controlled case series'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-22', 'studyFirstSubmitDate': '2020-05-16', 'studyFirstSubmitQcDate': '2020-05-16', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of anti-Müllerian (AMH) hormone', 'timeFrame': '6 months', 'description': 'Level of anti-Müllerian (AMH) hormone in female patients before and after radioactive iodine therapy.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Insufficiency', 'Radiation Exposure']}, 'descriptionModule': {'briefSummary': 'Thyroid carcinoma is the most common endocrine malignancy. Surgery is the standard therapeutic approach for patients with differentiated thyroid carcinoma (DTC), followed by radioiodine (RAI) therapy if indicated. For women with DTC, the effects of RAI therapy on gonadal and reproductive function are an important consideration. This study aimed to evaluate the effects of RAI therapy on ovarian function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient in childbearing period.\n* Female patient with differentiated thyroid carcinoma.\n* Underwent thyroidectomy.\n* Candidate for radioactive iodine therapy.\n\nExclusion Criteria:\n\n* • Male patients.\n\n * Postmenopausal female patients.\n * Female patients with undifferentiated thyroid carcinoma.\n * Pregnant female patients.\n * Lactating female patients.'}, 'identificationModule': {'nctId': 'NCT04396158', 'briefTitle': 'Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer', 'orgStudyIdInfo': {'id': 'ovarian reserve'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'interventionNames': ['Radiation: radioactive iodine']}], 'interventions': [{'name': 'radioactive iodine', 'type': 'RADIATION', 'description': '80-200 mCi of radioactive iodine will be given to thyroid cancer patients', 'armGroupLabels': ['intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of nuclear medicine', 'investigatorFullName': 'Hebat Allah Ahmed Askar', 'investigatorAffiliation': 'Assiut University'}}}}