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NCT Number: NCT03546387

Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients

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.

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Key information

Conditions

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

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Vittoria Arslan Carlon, MD

CONTACT

212-639-2680

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Comparing scores in neuropsychological testing results

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Abramson, MD

CONTACT

[email protected]

212-639-7232

Vittoria Arslan Carlon, MD

CONTACT

[email protected]

212-639-2680

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2018
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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