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Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546387
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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
Pediatric Retinoblastoma Retinoblastoma 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
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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : May 7, 2022
Estimated Study Completion Date : May 7, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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
  • Other: California Verbal Learning Test, Children's Version
    Used to assess verbal learning and memory in children and adolescents
  • Other: Beery Developmental Test of Visual Motor Integration, 6th edition
    Helps assess visual-motor skills in children and adults.
  • Other: Grooved Pegboard Test
    Measures dexterity
  • Other: 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.

Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric patients with retinoblastoma, between 6 and 16 years of age, at MSK.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546387


Contacts
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Contact: Vittoria Arslan Carlon, MD 212-639-2680 arslancv@mskcc.org
Contact: David Abramson, MD 212-639-7232 abramsod@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Vittoria Arslan Carlon, MD    212-639-2680      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Vittoria Arslan Carlon, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03546387    
Other Study ID Numbers: 18-126
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Retinoblastoma
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