Risk of Psychopathology and Neurocognitive Impairment in Leukemia Survivors

NCT01014195 | Completed

• 2 other identifiers: NEULSR01MH085849
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.This study will evaluate the association between changes in basic cognitive and behavioral functioning by the end of chemotherapy treatment, and the later development of higher order executive functions in pediatric acute lymphoblastic leukemia (ALL).
2. 2.The association between acute treatment-related changes in brain integrity and subsequent brain maturation in long-term survivors of pediatric ALL will be evaluated.
3. 3.The association between patterns of behavioral and executive dysfunction and brain maturation in long-term survivors of pediatric ALL will be examined.
4. 4.The association between genetic polymorphisms in key enzyme pathways and higher order brain development in long-term survivors of pediatric ALL will be explored.
5. 5.The associations between biologic and behavioral indices of fatigue/sleep and higher order brain development in long-term survivors of pediatric ALL will be explored.

Conditions

Neurocognitive Impairment; Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic Leukemia; Neurocognitive function; ADHD; brain imaging; genetic polymorphisms; Psychopathology and neurocognitive Impairment in Leukemia Survivors

Outcome Measures

Primary Outcomes (1)

• Neurocognitive assessment of attention, processing speed, and executive functions.

  Once, at least 5 years post ALL diagnosis and 2 years off treatment

Secondary Outcomes (4)

• Quantitative magnetic resonance imaging (MRI) and DTI and functional magnetic resonance imaging (fMRI) of brain structure and function.

  Once, at least 5 years post ALL diagnosis and 2 years off treatment

• Family and parental stress as reported by primary caregiver.

  Once, at least 5 years post ALL diagnosis and 2 years off treatment

• Associations between genetic polymorphisms in key enzyme pathways and higher order brain development in long-term survivors of pediatric ALL.

  Once, at least 5 years post ALL diagnosis and 2 years off treatment

• Associations between fatigue and neurocognitive performance and between sleep problems and neurocognitive performance.

  Once, at least 5 years post ALL diagnosis and 2 years off treatment

Study Arms (1)

Group 1

Survivors of pediatric leukemia treated on Total Therapy Protocol XV (TOTXV) at St. Jude Children's Research Hospital (SJCRH), who are ≥ 8 years of age and ≥ 5 years from diagnosis. Intervention: Neurocognitive and behavioral evaluation

Other: Neurocognitive and behavioral evaluation

Interventions

Neurocognitive and behavioral evaluation OTHER

The primary neurocognitive outcome will be performance on measures of cognitive flexibility and cognitive fluency. Functional behavior will be evaluated via the child or adult version of the Behavior Rating Inventory of Executive Function, using parent respondent for each version. The presence of ADHD and common comorbid conditions (i.e. depression, anxiety) will be determined with structured diagnostic interviews. Quality of life will be re-assessed with the PedQL.

Group 1

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children originally enrolled and treated on the SJCRH TOTXV protocol. The study has reviewed TOTXV patient database and has identified 343 patients (189 males and 154 females) who will meet the inclusion criteria (assuming no additional deaths or relapse).

You may qualify if:

• Enrolled on SJCRH TOTXV ALL protocol
• ≥ 5 years post diagnosis of ALL
• ≥ 8.0 years of age at time of follow-up evaluation

You may not qualify if:

• History of cranial or total-body radiation therapy
• History of bone marrow transplant
• History of relapse
• History of head injury, neurological condition unrelated to ALL treatment, or diagnosis of a genetic disorder associated with neurocognitive impairment (e.g. Down Syndrome)

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• Cheung YT, Sabin ND, Reddick WE, Bhojwani D, Liu W, Brinkman TM, Glass JO, Hwang SN, Srivastava D, Pui CH, Robison LL, Hudson MM, Krull KR. Leukoencephalopathy and long-term neurobehavioural, neurocognitive, and brain imaging outcomes in survivors of childhood acute lymphoblastic leukaemia treated with chemotherapy: a longitudinal analysis. Lancet Haematol. 2016 Oct;3(10):e456-e466. doi: 10.1016/S2352-3026(16)30110-7. Epub 2016 Sep 14.

  PMID: 27658980 DERIVED

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kevin Krull, Ph.D

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 16, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

US (1)