Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-26 @ 1:23 PM
Study NCT ID:
NCT01014195
Status:
COMPLETED
Last Update Posted:
2016-06-07
First Post:
2009-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Psychopathology and Neurocognitive Impairment in Leukemia Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2009-11-13', 'studyFirstSubmitQcDate': '2009-11-13', 'lastUpdatePostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurocognitive assessment of attention, processing speed, and executive functions.', 'timeFrame': 'Once, at least 5 years post ALL diagnosis and 2 years off treatment'}], 'secondaryOutcomes': [{'measure': 'Quantitative magnetic resonance imaging (MRI) and DTI and functional magnetic resonance imaging (fMRI) of brain structure and function.', 'timeFrame': 'Once, at least 5 years post ALL diagnosis and 2 years off treatment'}, {'measure': 'Family and parental stress as reported by primary caregiver.', 'timeFrame': 'Once, at least 5 years post ALL diagnosis and 2 years off treatment'}, {'measure': 'Associations between genetic polymorphisms in key enzyme pathways and higher order brain development in long-term survivors of pediatric ALL.', 'timeFrame': 'Once, at least 5 years post ALL diagnosis and 2 years off treatment'}, {'measure': 'Associations between fatigue and neurocognitive performance and between sleep problems and neurocognitive performance.', 'timeFrame': 'Once, at least 5 years post ALL diagnosis and 2 years off treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Lymphoblastic Leukemia', 'Neurocognitive function', 'ADHD', 'brain imaging', 'genetic polymorphisms', 'Psychopathology and neurocognitive Impairment in Leukemia Survivors'], 'conditions': ['Neurocognitive Impairment', 'Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '27658980', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': '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).\n2. The association between acute treatment-related changes in brain integrity and subsequent brain maturation in long-term survivors of pediatric ALL will be evaluated.\n3. The association between patterns of behavioral and executive dysfunction and brain maturation in long-term survivors of pediatric ALL will be examined.\n4. The association between genetic polymorphisms in key enzyme pathways and higher order brain development in long-term survivors of pediatric ALL will be explored.\n5. 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.', 'detailedDescription': 'Survival rates for pediatric acute lymphoblastic leukemia (ALL) now exceed 80%. With this growing population of long-term survivors comes recognition that a considerable proportion experience one or more significant late effects. For children undergoing central nervous system (CNS) treatment, common late effects include neurocognitive impairment and neurobehavioral problems. Although these problems first manifest as subtle difficulties with attention and processing speed, they can evolve into deficits in higher order brain functions that significantly impact functional skills in a subset of long-term survivors. There currently is no method to accurately identify patients at greatest risk for these long-term behavioral and neurocognitive problems. Through this proposal, this study plans to utilize existing data collected during acute treatment to identify predictors of long-term neurocognitive and brain maturation outcomes. The study also proposes to collect data on attention-deficit/hyperactivity disorder (ADHD) and associated comorbidities, higher order executive functions, and structural and functional brain imaging in survivors who are at least 8 years of age and greater than 5 years from diagnosis.\n\nAll patients will undergo a single neurocognitive evaluation focused on assessment of higher order executive functions. Patients will be evaluated during their regularly scheduled annual follow-up visit, when health-related monitoring will also occur. Parents of participants will be asked to complete questionnaires designed to assess the family environment and the impact of cancer diagnosis on family functioning and parent stress.\n\nBrain Imaging: To better demonstrate untoward treatment effects upon cortical brain development, quantitative MR imaging of myelin integrity using diffusion tensor imaging (DTI) and cortical thickness assessment using high resolution volumetric imaging will be utilized. All patients will also be evaluated using functional MRI (fMRI) procedures during resting state and participation in attention and working memory tasks. fMRI and DTI data will be de-identified then analyzed at MD Anderson Cancer Center in Houston, Texas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled on SJCRH TOTXV ALL protocol\n* ≥ 5 years post diagnosis of ALL\n* ≥ 8.0 years of age at time of follow-up evaluation\n\nExclusion Criteria:\n\n* History of cranial or total-body radiation therapy\n* History of bone marrow transplant\n* History of relapse\n* History of head injury, neurological condition unrelated to ALL treatment, or diagnosis of a genetic disorder associated with neurocognitive impairment (e.g. Down Syndrome)'}, 'identificationModule': {'nctId': 'NCT01014195', 'briefTitle': 'Risk of Psychopathology and Neurocognitive Impairment in Leukemia Survivors', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Risk of Psychopathology and Neurocognitive Impairment in Leukemia Survivors', 'orgStudyIdInfo': {'id': 'NEULS'}, 'secondaryIdInfos': [{'id': 'R01MH085849', 'link': 'https://reporter.nih.gov/quickSearch/R01MH085849', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': "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.\n\nIntervention: Neurocognitive and behavioral evaluation", 'interventionNames': ['Other: Neurocognitive and behavioral evaluation']}], 'interventions': [{'name': 'Neurocognitive and behavioral evaluation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Kevin Krull, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}