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Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03546387
Collaborator
(none)
75
Enrollment
1
Location
60
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)
  • Other: California Verbal Learning Test, Children's Version
  • Other: Beery Developmental Test of Visual Motor Integration, 6th edition
  • Other: Grooved Pegboard Test
  • Other: Behavior Assessment System for Children/Parent Report

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Incidence of Neurocognitive Deficits in Patients After Treatment for Retinoblastoma With Multiple Anesthesia Exposures
Actual Study Start Date :
May 7, 2018
Anticipated Primary Completion Date :
May 7, 2023
Anticipated Study Completion Date :
May 7, 2023

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age ≥ 6 and < 17 years old

  • Ability to undergo at least one eye examination without anesthesia prior to current visit

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Vittoria Arslan Carlon, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT03546387
Other Study ID Numbers:
  • 18-126
First Posted:
Jun 6, 2018
Last Update Posted:
Jun 2, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
18-126
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
Retinoblastoma

Study Results

No Results Posted as of Jun 2, 2022