Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-02-01 @ 12:22 PM
Study NCT ID:
NCT00410618
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2006-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurological Effects of Chemotherapy and Radiation Therapy in Patients With Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2006-12-11', 'studyFirstSubmitQcDate': '2006-12-11', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nature and long-term ramifications of CNS injury as a result of cancer treatment'}], 'secondaryOutcomes': [{'measure': 'Differences in cognitive measures and MRI data'}, {'measure': 'Relationship between MRI measures and cognitive performance'}]}, 'conditionsModule': {'keywords': ['cognitive/functional effects', 'long-term effects secondary to cancer therapy in adults', 'recurrent colon cancer', 'stage I colon cancer', 'stage II colon cancer', 'stage III colon cancer', 'stage IV colon cancer'], 'conditions': ['Cognitive/Functional Effects', 'Colorectal Cancer', 'Long-term Effects Secondary to Cancer Therapy in Adults']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Learning about the long-term effects of chemotherapy and radiation therapy on brain function may help doctors plan cancer treatments.\n\nPURPOSE: This clinical trial is looking at the neurological effects of chemotherapy and radiation therapy in patients with colon cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Identify the nature and long-term ramifications of CNS injury as a result of cancer treatment in patients with colon cancer.\n\nSecondary\n\n* Analyze differences in cognitive measures and MRI data in these patients.\n* Correlate MRI measures with cognitive performance in these patients.\n\nOUTLINE: Patients undergo cognitive performance assessment and MRI.\n\nPROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Colon cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of colon cancer\n* Received chemotherapy and radiotherapy for colon cancer\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00410618', 'briefTitle': 'Neurological Effects of Chemotherapy and Radiation Therapy in Patients With Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Neurological Effects of Chemotherapy and Radiation Treatment: Colon Cancer', 'orgStudyIdInfo': {'id': 'HSCB0213'}, 'secondaryIdInfos': [{'id': 'P50CA095060', 'link': 'https://reporter.nih.gov/quickSearch/P50CA095060', 'type': 'NIH'}, {'id': 'P30CA023074', 'link': 'https://reporter.nih.gov/quickSearch/P30CA023074', 'type': 'NIH'}, {'id': 'UARIZ-BSC-02-13', 'type': 'OTHER', 'domain': 'University of Arizona'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cognitive assessment', 'type': 'PROCEDURE'}, {'name': 'magnetic resonance imaging', 'type': 'PROCEDURE'}, {'name': 'management of therapy complications', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724-5024', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Sheryl Reminger, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}