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Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03546387
Enrollment
75
Registered
2018-06-06
Start date
2018-05-07
Completion date
2026-05-07
Last updated
2025-07-03

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

Conditions

Pediatric Retinoblastoma, Retinoblastoma

Keywords

18-126, Memorial Sloan Kettering Cancer Center

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.

Interventions

Measures dexterity

the WISC-V assessment produces a Full Scale IQ (FSIQ) used for primary power consideration in this study. The FSIQ is the most comprehensive global ability score on the WISC-V, and it has been conventionally reported and interpreted as an estimation of overall intellectual ability

OTHERCalifornia Verbal Learning Test, Children's Version

Used to assess verbal learning and memory in children and adolescents

OTHERBeery Developmental Test of Visual Motor Integration, 6th edition

Helps assess visual-motor skills in children and adults.

OTHERBehavior Assessment System for Children/Parent Report

The Behavior Assessment System for Children/Parent Report is a questionnaire that assesses the social-emotional and behavioral functioning (e.g., anxiety, depression, attention, hyperactivity, adaptability, leadership, social skills, etc.) in children between the ages of 2 and 22 years, and is available in English and Spanish.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparing scores in neuropsychological testing results6 weeksThe 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.

Countries

United States

Contacts

Primary ContactVittoria Arslan Carlon, MD
arslancv@mskcc.org212-639-2680
Backup ContactDavid Abramson, MD
abramsod@mskcc.org212-639-7232

Outcome results

None listed

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