Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02375451
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2014-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Childhood Radioiodine Therapy on Salivary Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614965', 'term': 'Iodine-131'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-23', 'studyFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary function (MST value)', 'timeFrame': '0 to 50 years after radioiodine treatment', 'description': 'sterile paper strip is used to measure saliva production (noninvasive testing)'}, {'measure': 'Responses to Dry Mouth Questionnaire', 'timeFrame': 'At time of visit up to 4 months thereafter.', 'description': 'Patient questionnaire/survey'}], 'secondaryOutcomes': [{'measure': 'Caries history (number of caries noted in dental records)', 'timeFrame': '1 year before radioiodine administration to 4 months after study visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Xerostomia', 'Hyperthyroidism', 'Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease.', 'detailedDescription': 'Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease. We will use a Modified Shirmer Test to measure saliva production and a questionnaire to evaluation symptoms of xerostomia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have receive I-131 therapy in childhood for thyroid disease, compared to a control group of patients who have never receive I-131 therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been treated with radioiodine therapy\n* Patients who have never received radioiodine therapy (negative control group)\n\nExclusion Criteria:\n\n* Non-English speaking subjects will be excluded due to our lack of translation support resources at this time. Of note, participation in our study cannot benefit participants in any way.'}, 'identificationModule': {'nctId': 'NCT02375451', 'briefTitle': 'Effect of Childhood Radioiodine Therapy on Salivary Function', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Effect of Childhood Radioiodine Therapy on Salivary Function', 'orgStudyIdInfo': {'id': 'IRB-P00012399'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radioiodine', 'description': 'Patients with a history of childhood treatment with radioiodine will be assessed for symptoms of salivary function and measurement of saliva production. These data will be compared to a normal control group.', 'interventionNames': ['Other: Radioiodine']}, {'label': 'Control', 'description': 'Patients who are similar in age to those in the Radioiodine group, but who did not recieve I-131 therapy.'}], 'interventions': [{'name': 'Radioiodine', 'type': 'OTHER', 'description': "We will determine if prior radioiodine treatment in childhood impacts salivary function or symptoms. Radioiodine treatment will have been determined by the patient's medical condition and care (NOT assigned by this research study).", 'armGroupLabels': ['Radioiodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Thyroid Program, Division of Endocrinology', 'investigatorFullName': 'Ari Wassner', 'investigatorAffiliation': "Boston Children's Hospital"}}}}