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Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children

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ClinicalTrials.gov Identifier: NCT03866460
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Intraocular Retinoblastoma Hearing Loss Diagnostic Test: Distortion product otoacoustic emission measurement (DPOAE)

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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 2021
Estimated Study Completion Date : March 2021


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be identified from the retinoblastoma clinic when the treatment plan includes IA carboplatin chemotherapy.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mary Elizabeth Davis, MSN, RN, AOCNS 212-639-3147 davism@mskcc.org
Contact: Margaret Barton-Burke, PhD, RN, FAAN 646-449-1074

Locations
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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      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Mary Elizabeth Davis, MSN, RN, AOCNS Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03866460     History of Changes
Other Study ID Numbers: 18-529
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Hearing Status
18-529

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Retinoblastoma
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases, Hereditary
Eye Diseases
Retinal Diseases
Carboplatin
Antineoplastic Agents