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Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03866460
Enrollment
30
Registered
2019-03-07
Start date
2019-03-06
Completion date
2024-11-04
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Intraocular Retinoblastoma

Keywords

Hearing Status, 18-529

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.

Interventions

DIAGNOSTIC_TESTDistortion product otoacoustic emission measurement (DPOAE)

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

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Estimate the incidence of hearing loss1 yearwill 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026