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Clinical Trials/NCT03546387
NCT03546387
Recruiting
N/A

Incidence of Neurocognitive Deficits in Patients After Treatment for Retinoblastoma With Multiple Anesthesia Exposures

Memorial Sloan Kettering Cancer Center1 site in 1 country75 target enrollmentMay 7, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Retinoblastoma
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
75
Locations
1
Primary Endpoint
Comparing scores in neuropsychological testing results
Status
Recruiting
Last Updated
10 months ago

Overview

Brief Summary

The purpose of this study is to see if there is a difference between the development of the brain (neurodevelopment) in children who have been treated for retinoblastoma with multiple anesthetic exposures, compared with brain development in children who have never had anesthesia.

Registry
clinicaltrials.gov
Start Date
May 7, 2018
End Date
May 7, 2026
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 6 and \< 17 years old

Exclusion Criteria

  • Diagnosis of any secondary disease associated with developmental delay
  • History of second cancer diagnosis
  • Legal Blindness
  • Past surgery of any type, with the exception of enucleation for retinoblastoma
  • Past exposure to anesthesia for surgical intervention
  • More than one anesthesia encounter for surgical intervention before diagnosis at MSK
  • Past External Beam Radiation for treatment of retinoblastoma
  • Past systemic chemotherapy
  • Non-native speaker of English; however, children whose parents speak only Spanish will be included, because the tests for parents are available in Spanish

Outcomes

Primary Outcomes

Comparing scores in neuropsychological testing results

Time Frame: 6 weeks

The primary outcome is based on the Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measured at follow up. The 5 primary index scores on the WISC-V (Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed) are based on 10 subtests and represent intellectual functioning in different cognitive areas. Similar to the FSIQ, the primary index scores are on a standard score metric with a mean of 100 (SD=15). The WISC-V consists of 16 subtests; each subtest is based on a scaled score metric with a mean of 10 and standard deviation (SD) of 3. Performance on these domain-specific subtests will be summarized and analyzed similarly to the FSIQ.

Study Sites (1)

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