Determination of Hearing Status in Children Receiving Intra-Arterial Carboplatin for Intraocular Retinoblastoma

Memorial Sloan Kettering Cancer Center1 site in 1 country30 target enrollmentMarch 6, 2019

ConditionsIntraocular Retinoblastoma Hearing Loss

Overview

Phase: N/A
Intervention: Not specified
Conditions: Intraocular Retinoblastoma
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 30
Locations: 1
Primary Endpoint: Estimate the incidence of hearing loss
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 6, 2019

End Date

November 4, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

•Children with known and documented preexisting hearing loss.

Outcomes

Primary Outcomes

Estimate the incidence of hearing loss

Time Frame: 1 year

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.