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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

Tracking Information
First Submitted Date March 6, 2019
First Posted Date March 7, 2019
Last Update Posted Date March 7, 2019
Actual Study Start Date March 6, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children
Official Title Determination of Hearing Status in Children Receiving Intra-Arterial Carboplatin for Intraocular Retinoblastoma
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients will be identified from the retinoblastoma clinic when the treatment plan includes IA carboplatin chemotherapy.
Condition
  • Intraocular Retinoblastoma
  • Hearing Loss
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Distortion product otoacoustic emission measurement (DPOAE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 6, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mary Elizabeth Davis, MSN, RN, AOCNS 212-639-3147 davism@mskcc.org
Contact: Margaret Barton-Burke, PhD, RN, FAAN 646-449-1074
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03866460
Other Study ID Numbers 18-529
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Mary Elizabeth Davis, MSN, RN, AOCNS Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date March 2019