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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: Completed study of Leukemia and Down Syndrome, sponsored by St. Jude Children's Research Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Descriptive statistics will be estimated.
Conditions Studied
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2016-08-18 |
| Est. Completion | 2019-01-31 |
What the finished NCT02859389 record still lists
NCT02859389 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Leukemia appearing as the primary indexed condition, and to 0 interventions.
NCT02859389 reports a single indexed study location in 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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Where NCT02859389's enrollment target sits among peer trials
43 126th of 233 higher than 108 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
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