Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00873132
Status:
WITHDRAWN
Last Update Posted:
2013-06-19
First Post:
2009-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BTC Neuropsychological Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No Funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2009-03-30', 'studyFirstSubmitQcDate': '2009-03-31', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bivariate correlational analyses will be conducted to examine associations between neuropsychological, depression, demographic, medication data tumor-related treatment , and QoL variables.', 'timeFrame': '5years'}], 'secondaryOutcomes': [{'measure': 'In exploratory analyses, FACT-BR scale scores will be regressed on candidate neurocognitive predictors while controlling for other potentially confounding variables using hierarchical regression analyses.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brain Tumor']}, 'descriptionModule': {'briefSummary': "Purpose and Objective:\n\nThe purpose of this study is to collect data both retrospectively and prospectively, by consent, on subjects seen in the PRTBTC. This information will be useful to the investigators to generate hypotheses for planning further psychosocial and medication intervention studies that will hopefully improve primary brain tumor patients' QOL.", 'detailedDescription': 'Study Activities and Population Group:\n\nRetrospective dates will be 3/1/06 through the approval date for the prospective component of this study. The data will be neurocognitive, depression, tumor-related, overall quality of life (QOL), treatment, and demographic variables. The investigators research aims are to\n\n* compute correlations among these different variables\n* to test significant predictors of QOL. The investigators also will conduct a retrospective review of all brain tumor patients evaluated at the neuropsychology clinic at the PRT-BTC from the date that this prospective study is approved back to 3/20/2006.\n\nData Analysis and Risk/Safety Issues:\n\nThe medical record review does not present any obvious source of risk or discomfort to patients and their families. For both the retrospective and prospective components of the study, as the data for the proposed study were already collected as a part of the standard of care at the Preston Robert Tisch Brain Tumor Center at Duke, there are no additional risks to the study sample as a result of data collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For those patients enrolled, we will conduct analysis on data that is gathered during neuropsychological testing visits to better describe the pattern of neurocognitive deficits typically seen in our patient population and to publish our findings with the goal of informing a larger scientific community.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Data collected both retrospectively and prospectively, by consent, on subjects with brain tumors seen in the Preston Robert Tisch Brain Tumor Center (PRTBTC).\n* Retrospective dates will be 3/1/06 through the approval date for the prospective component of this study.\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT00873132', 'briefTitle': 'BTC Neuropsychological Database', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'BTC Neuropsychological Database:Prospective Study', 'orgStudyIdInfo': {'id': 'Pro00012450'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Data Collection', 'description': 'Collect data both retrospectively and prospectively on subjects seen at the Preston Robert Tisch Brain Tumor Center'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Renee Raynor, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}