Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 6 and < 17 years old
Disqualifiers
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
Trial population
pediatric patients with retinoblastoma, between 6 and 16 years of age, at MSK.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)
Other interventionthe 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
California Verbal Learning Test, Children's Version
Other interventionUsed to assess verbal learning and memory in children and adolescents
Beery Developmental Test of Visual Motor Integration, 6th edition
Other interventionHelps assess visual-motor skills in children and adults.
Grooved Pegboard Test
Other interventionMeasures dexterity
Behavior Assessment System for Children/Parent Report
Other interventionThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Comparing scores in neuropsychological testing results
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.
Time frame
6 weeksSponsors and contacts
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Source ClinicalTrials.gov