Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT03866460
Status:
COMPLETED
Last Update Posted:
2024-11-07
First Post:
2019-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2019-03-06', 'studyFirstSubmitQcDate': '2019-03-06', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate the incidence of hearing loss', 'timeFrame': '1 year', 'description': 'will be defined as a \\>10 db loss from baseline in any frequency, based on the lower threshold of the American Speech and Hearing Associations (ASHA) hearing change criteria. For children unable to cooperate for an audiogram, the DPOAE will be the primary measurement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hearing Status', '18-529'], 'conditions': ['Intraocular Retinoblastoma', 'Hearing Loss']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out how often hearing loss occurs in patients with retinoblastoma after receiving treatment with intra-arterial carboplatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be identified from the retinoblastoma clinic when the treatment plan includes IA carboplatin chemotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent indicating awareness of the investigational nature of the protocol.\n* Children with RB aged 3 months and older who are scheduled to receive their first dose of IA carboplatin chemotherapy.\n\n * Retinoblastoma is rarely seen in children over 8 years old, however we will not include an upper age range so as not to exclude any possible participants\n\nExclusion Criteria:\n\n* Children with known and documented preexisting hearing loss.'}, 'identificationModule': {'nctId': 'NCT03866460', 'briefTitle': 'Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Determination of Hearing Status in Children Receiving Intra-Arterial Carboplatin for Intraocular Retinoblastoma', 'orgStudyIdInfo': {'id': '18-529'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hearing evaluation DPOAE', 'description': 'Post IA hearing evaluation will be allowed up until 9 months after IA completion (or roughly one year from initiation of treatment). After completion of standard treatment for RB that included IA carboplatin.', 'interventionNames': ['Diagnostic Test: Distortion product otoacoustic emission measurement (DPOAE)']}], 'interventions': [{'name': 'Distortion product otoacoustic emission measurement (DPOAE)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hearing will be measured at baseline and 3-9 months after completion of treatment with IA carboplatin chemotherapy.', 'armGroupLabels': ['Hearing evaluation DPOAE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mary Elizabeth Davis, MSN, RN, AOCNS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}