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NCT02859389 · ClinicalTrials.gov registry record

Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome

A clinical trial of Leukemia and Down Syndrome, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
43
Enrollment target
1
Study location

NCT02859389 is a study of Leukemia and Down Syndrome that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 43 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02859389, a study of Leukemia and Down Syndrome, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
43 participants
Enrollment target
1
Study location

Study Summary

Survivors of acute lymphoblastic leukemia (ALL) are at risk for neurocognitive deficits, reduced educational and psychosocial outcomes, and lower quality of life. Neurocognitive assessment is frequently implemented during therapy and continued into survivorship to monitor functioning and to facilitate intervention. Children with Down Syndrome (DS) are at 10 to 20-fold increased risk for leukemia. Survival rates for leukemia patients with DS are comparable to or lower than patients without DS, however, these patients are at greater risk for treatment-related toxicities. Children with preexisting neurodevelopmental conditions, including DS, are systematically excluded from neurocognitive assessment on clinical trials, contributing to a gap in the investigators understanding of outcomes in these patients with preexisting neurocognitive vulnerability. The investigators propose a novel preliminary investigation of functional outcomes in children with DS and childhood leukemia. This study has implications for future treatment of leukemia patients with DS, and may generalize to leukemia patients with other predispositions or preexisting neurodevelopmental conditions (e.g., genetic disorders, acquired brain injury, autism, and epilepsy). Primary Objective: * To describe neurocognitive and psychosocial outcomes in survivors of childhood leukemia with Down Syndrome using a novel assessment approach.

Conditions Studied

Study Locations (1)

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2016-08-18
Est. Completion 2019-01-31

What the Registry Record Tells You About NCT02859389

The ClinicalTrials.gov registry entry for NCT02859389 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (91% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Leukemia appearing as the primary indexed condition, and to 0 interventions.

NCT02859389 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT02859389 about?

NCT02859389 is a clinical study titled "Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome". Survivors of acute lymphoblastic leukemia (ALL) are at risk for neurocognitive deficits, reduced educational and psychosocial outcomes, and lower quality of life. Neurocognitive assessment is frequently implemented during therapy and continued into survivorship to monitor functioning and to facilita...

What is the current status of trial NCT02859389?

This trial is currently completed. The enrollment target is 43 participants. The study started on 2016-08-18. Estimated completion is 2019-01-31.

What conditions does trial NCT02859389 study?

This clinical trial studies the following conditions: Leukemia, Down Syndrome.

Who is sponsoring clinical trial NCT02859389?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02859389 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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