Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients

Retinoblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03546387
• Other study ID #: 18-126
• Status: Recruiting
• Start date: May 7, 2018
• Est. completion date: May 7, 2025

Study information

• Verified date: June 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Vittoria Arslan Carlon, MD
• Phone: 212-639-2680
• Email: arslancv[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 7, 2025
• Est. primary completion date: May 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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 purposes other than retinoblastoma examination

• More than one anesthesia encounter 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

Related Conditions & MeSH terms

• Pediatric Retinoblastoma
• Retinoblastoma

Intervention

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
• California Verbal Learning Test, Children's Version
Used to assess verbal learning and memory in children and adolescents
• Beery Developmental Test of Visual Motor Integration, 6th edition
Helps assess visual-motor skills in children and adults.
• Grooved Pegboard Test
Measures dexterity
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks

External Links

•   Memorial Sloan Kettering Cancer Center