Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients

NCT03546387 | Recruiting

• 1 other identifier: 18-126
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Retinoblastoma; Retinoblastoma

Keywords

18-126; Memorial Sloan Kettering Cancer Center

Outcome Measures

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.

  6 weeks

Interventions

Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) OTHER

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 OTHER

Used to assess verbal learning and memory in children and adolescents

Beery Developmental Test of Visual Motor Integration, 6th edition OTHER

Helps assess visual-motor skills in children and adults.

Grooved Pegboard Test OTHER

Measures dexterity

Behavior Assessment System for Children/Parent Report OTHER

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.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric patients with retinoblastoma, between 6 and 16 years of age, at MSK.

You may qualify if:

• Age ≥ 6 and \< 17 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Retinoblastoma

Interventions

Wechsler Scales; Memory and Learning Tests

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Intelligence Tests; Aptitude Tests; Psychological Tests; Behavioral Disciplines and Activities; Neuropsychological Tests

Study Officials

• Vittoria Arslan Carlon, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vittoria Arslan Carlon, MD

CONTACT

212-639-2680; arslancv@mskcc.org

David Abramson, MD

CONTACT

212-639-7232; abramsod@mskcc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 6, 2018
• Study Start: May 7, 2018
• Primary Completion: May 7, 2026
• Study Completion: May 7, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

US (1)