Leukemia Clinical Trial
Official title:
Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome
NCT number | NCT02859389 |
Other study ID # | DSCOG |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 18, 2016 |
Est. completion date | January 31, 2019 |
Verified date | September 2018 |
Source | St. Jude Children's Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patient is an SJCRH patient with a diagnosis of leukemia. - Diagnosis of Trisomy 21 DS as documented in the medical record - Completed all cancer-directed therapy at SJCRH, since 1980, and at least 6 months prior to the study visit - English as the primary language Exclusion Criteria: - Documented history of central nervous system (CNS) injury or disease that occurred after completing cancer-directed therapy - History of or current substance use or abuse |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurocognitive Outcome | Descriptive statistics will be estimated. | Once at participant enrollment | |
Primary | Psychosocial Outcome | Descriptive statistics will be estimated. | Once at participant enrollment |
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