Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome
|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: NCT02859389|
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : September 11, 2018
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).
- To describe neurocognitive and psychosocial outcomes in survivors of childhood leukemia with Down Syndrome using a novel assessment approach.
|Condition or disease|
|Leukemia Down Syndrome|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome|
|Actual Study Start Date :||August 18, 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
- Neurocognitive Outcome [ Time Frame: Once at participant enrollment ]Descriptive statistics will be estimated.
- Psychosocial Outcome [ Time Frame: Once at participant enrollment ]Descriptive statistics will be estimated.
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): NCT02859389
|Contact: Lisa M. Jacola, PhDfirstname.lastname@example.org|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Lisa M. Jacola, PhD 866-278-5833 email@example.com|
|Principal Investigator: Lisa M. Jacola, PhD|
|Principal Investigator:||Lisa M. Jacola, PhD||St. Jude Children's Research Hospital|