Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children
Determination of Hearing Status in Children Receiving Intra-Arterial Carboplatin for Intraocular Retinoblastoma
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2019
CompletedStudy Start
First participant enrolled
March 6, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2024
CompletedNovember 7, 2024
November 1, 2024
5.7 years
March 6, 2019
November 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimate the incidence of hearing loss
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.
1 year
Study Arms (1)
Hearing evaluation DPOAE
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.
Interventions
Hearing will be measured at baseline and 3-9 months after completion of treatment with IA carboplatin chemotherapy.
Eligibility Criteria
Patients will be identified from the retinoblastoma clinic when the treatment plan includes IA carboplatin chemotherapy.
You may qualify if:
- Signed informed consent indicating awareness of the investigational nature of the protocol.
- Children with RB aged 3 months and older who are scheduled to receive their first dose of IA carboplatin chemotherapy.
- 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
You may not qualify if:
- Children with known and documented preexisting hearing loss.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Elizabeth Davis, MSN, RN, AOCNS
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2019
First Posted
March 7, 2019
Study Start
March 6, 2019
Primary Completion
November 4, 2024
Study Completion
November 4, 2024
Last Updated
November 7, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
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.