Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients

Recruiting

• Conditions: Retinoblastoma; Pediatric Retinoblastoma

• Registration Number: NCT03546387
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-07
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-05-07
• Study Completion: 2025-05-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Age ≥ 6 and < 17 years old

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing scores in neuropsychological testing results	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States