Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-31 @ 9:48 PM
Study NCT ID:
NCT03202160
Status:
UNKNOWN
Last Update Posted:
2017-06-28
First Post:
2017-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Causes of Goiter in Children Attending Assiut University Children Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006042', 'term': 'Goiter'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2019-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-27', 'studyFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum T3 and T4', 'timeFrame': '1 day', 'description': 'Serum T3 and T4 for diagnosis of cause of goiter'}, {'measure': 'Neck ultrasonography', 'timeFrame': '1 day', 'description': 'Neck ultrasonography for confirmation of diagnosis of goiter and for diagnosis of cause of goiter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Goiter'], 'conditions': ['Goiter']}, 'referencesModule': {'references': [{'pmid': '20084235', 'type': 'BACKGROUND', 'citation': 'Muirhead S. Diagnostic approach to goitre in children. Paediatr Child Health. 2001 Apr;6(4):195-9. doi: 10.1093/pch/6.4.195.'}]}, 'descriptionModule': {'briefSummary': 'Thyroid disorders are one of the most common endocrine problems in children and adolescents. Diagnostic considerations can be approached from the perspective of the goiter.A goiter, or thyromegaly, is an enlargement of the thyroid gland.Persons with enlarged thyroids can have normal function of the gland (euthyroidism), thyroid deficiency (hypothyroidism), or overproduction of the hormones (hyperthyroidism).', 'detailedDescription': "Congenital goiter most commonly occurs in neonates born to mothers with known thyroid disease especially Graves' disease. Other causes of congenital goitrous hypothyroidism are thyroid dyshormonogenesis, endemic iodine deficiency and maternal goitrogen ingestion or iodine excess (expectorants, povidone iodine).\n\nThe most common causes of euthyroid goiter in childhood are chronic lymphocytic thyroiditis and a colloid goiter (simple goiter). Thyroid enlargement that is not caused by inflammatory, infectious or neoplastic causes is termed a colloid goiter, also.\n\nChronic lymphocytic thyroiditis , also known as Hashimoto thyroiditis, is an autoimmune, inflammatory process that causes up to 55% to 65% of all euthyroid goiters, and almost all cases of thyroiditis in childhood and adolescence. A large North American prevalence study showed that as many as 1.2% of children aged 11 to18 years have chronic lymphocytic thyroiditis, as defined by an enlarged thyroid gland and detectable serum thyroid antibodies.\n\nThyroid nodules are relatively common in adolescents; these nodules are usually asymptomatic and often discovered incidentally, but they raise the fear of cancer. A multi-nodular goiter is almost invariably caused by Hashimoto's thyroiditis and it carries a good prognosis. The asymptomatic, solitary thyroid nodule is a thyroid adenoma, thyroid carcinoma or a thyroid cyst. Thyroid carcinoma occurs in approximately one per one million persons/year in the first-two decades of life.\n\nNo reported data are found as regard of causes of goiter in children in our locality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All cases of goiter attending Assiut University hospitals of ages since birth up to 18 years old in the period of study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children of both sexes of ages since birth up to 18 years old who are presented by goiter.\n\nExclusion Criteria:\n\n* Any patient with neck swelling other than goiter.\n* Refusal of participation.'}, 'identificationModule': {'nctId': 'NCT03202160', 'briefTitle': 'Causes of Goiter in Children Attending Assiut University Children Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Cases of Goiter in Children Attending Assiut University Children Hospital', 'orgStudyIdInfo': {'id': 'CGCA'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hanaa A Mohammed, MD', 'role': 'CONTACT', 'email': 'hae50@hotmail.com', 'phone': '00201120096055', 'phoneExt': 'Assiut'}, {'name': 'Eman A Abdel-Raoof, MD', 'role': 'CONTACT', 'email': 'emanaskar@hotmail.com', 'phone': '00201099696173', 'phoneExt': 'Assiut'}], 'overallOfficials': [{'name': 'Hanaa A Mohammed, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'MAAta', 'investigatorAffiliation': 'Assiut University'}}}}