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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03546387
Other study ID # 18-126
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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