Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-06

Study Completion Date

2024-11-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Intraocular Retinoblastoma Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Distortion product otoacoustic emission measurement (DPOAE)

Intervention Type DIAGNOSTIC_TEST

Hearing will be measured at baseline and 3-9 months after completion of treatment with IA carboplatin chemotherapy.

Interventions

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Distortion product otoacoustic emission measurement (DPOAE)

Hearing will be measured at baseline and 3-9 months after completion of treatment with IA carboplatin chemotherapy.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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