Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V), California Verbal Learning Test, Children's Version, Beery Developmental Test of Visual Motor Integration, 6th edition, Grooved Pegboard Test.
- Who it may be relevant to
- Registry conditions: Pediatric Retinoblastoma, Retinoblastoma. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Incidence of Neurocognitive Deficits in Patients After Treatment for Retinoblastoma With Multiple Anesthesia Exposures
Overview
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
- Other Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)
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 - Other California Verbal Learning Test, Children's Version
Used to assess verbal learning and memory in children and adolescents - Other Beery Developmental Test of Visual Motor Integration, 6th edition
Helps assess visual-motor skills in children and adults. - Other Grooved Pegboard Test
Measures dexterity - Other Behavior 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.
Primary outcome measures
- Comparing scores in neuropsychological testing results [Time frame: 6 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center — New York
Identifiers
NCT: NCT03546387 · 18-126