Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03866460|
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : December 21, 2020
|Condition or disease||Intervention/treatment|
|Intraocular Retinoblastoma Hearing Loss||Diagnostic Test: Distortion product otoacoustic emission measurement (DPOAE)|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Determination of Hearing Status in Children Receiving Intra-Arterial Carboplatin for Intraocular Retinoblastoma|
|Actual Study Start Date :||March 6, 2019|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
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.
Diagnostic Test: Distortion product otoacoustic emission measurement (DPOAE)
Hearing will be measured at baseline and 3-9 months after completion of treatment with IA carboplatin chemotherapy.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866460
|Contact: Mary Elizabeth Davis, MSN, RN, AOCNSemail@example.com|
|Contact: Margaret Barton-Burke, PhD, RN, FAAN||646-449-1074|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Mary Elizabeth Davis, MSN, RN, AOCNS 212-639-3147|
|Contact: Margaret Barton-Burke, PhD, RN, FAAN 646-449-1074|
|Principal Investigator:||Mary Elizabeth Davis, MSN, RN, AOCNS||Memorial Sloan Kettering Cancer Center|