Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 6 to 17 years
• All sexes
• No healthy volunteers
• Child

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Pediatric Retinoblastoma, Retinoblastoma

Being tested

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

Keywords

18-126, Memorial Sloan Kettering Cancer Center

Medical subject headings

Retinoblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 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 VersionOther

  Used to assess verbal learning and memory in children and adolescents

• Beery Developmental Test of Visual Motor Integration, 6th editionOther

  Helps assess visual-motor skills in children and adults.

• Grooved Pegboard TestOther

  Measures dexterity

• Behavior Assessment System for Children/Parent ReportOther

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Jun 2018
2. Study start7 May 2018
3. Primary completion7 May 2027 (estimated)
4. Study completion7 May 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Pediatric RetinoblastomaStudies of the same condition, open and under way.
• More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.