Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT00490334
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2007-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2007-06-20', 'studyFirstSubmitQcDate': '2007-06-20', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance on neuropsychological testing and brain activation patterns measured by functional MRI', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Carcinomas', 'Squamous Cel', 'Adenocarcinoma', 'Acute Lymphocytic Leukemia'], 'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'This research involves assessment of cognitive outcome in childhood cancer as well as evaluation of a cognitive rehabilitation program for improving learning and problem solving difficulties in children with cancer.', 'detailedDescription': 'The purpose of this study is to help determine specific cognitive-behavioral and neurobiologic impairments associated with chemotherapy treatments in children with cancer and to assess the efficacy of a cognitive intervention program for improving cognitive impairments in these children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric cancer patients 8 to 16 years of age, with age- and gender-matched control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION\n\nEveryone:\n\n* At least 9 years of age and less than 17 years\n\nPatients\n\n* Diagnosis of brain tumor or acute lymphocytic leukemia (ALL)\n* Completed all anti-cancer treatment(s) including chemotherapy, radiation and/or surgery\n\nControl group\n\n* Typical for age\n\nEXCLUSION\n\nEveryone:\n\n* Non-English speaking (translated cognitive testing and MRI assessments unavailable)\n* MRI contraindication, including but not limited to orthodontia, metal implants, and/or pacemaker\n* Major sensory deficit disorders, including but not limited to blindness or deafness\n\nPatients\n\n* Shunt placement\n* Received bone marrow transplant\n* History of neurologic, psychiatric, developmental or major medical condition (eg, diabetes) NOT related to cancer\n* Participation in any concurrent cognitive rehabilitation study\n\nControl group\n\n* History of neurologic, psychiatric, developmental or major medical condition (eg, diabetes)'}, 'identificationModule': {'nctId': 'NCT00490334', 'briefTitle': 'Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer', 'orgStudyIdInfo': {'id': 'IRB-08123'}, 'secondaryIdInfos': [{'id': '97817', 'type': 'OTHER', 'domain': 'Stanford University Alternate IRB Approval Number'}, {'id': 'PEDSVAR0003', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer patients', 'description': 'Children with cancer aged 8 to 16 years'}, {'label': 'Control (non-cancer)', 'description': 'Normal children aged 8 to 16 years, age- and gender-matched to the cancer cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Shelli Kesler', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}