BTC Neuropsychological Database

Withdrawn

• Conditions: Brain Tumor

• Registration Number: NCT00873132
• Lead Sponsor: Duke University

Brief Summary

Purpose and Objective:

The 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.

Detailed Description

Study Activities and Population Group:

Retrospective 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

* compute correlations among these different variables

* 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.

Data Analysis and Risk/Safety Issues:

The 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-31
• Study Start: 2009-04
• Study First Posted: 2009-04-01
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Data collected both retrospectively and prospectively, by consent, on subjects with brain tumors seen in the Preston Robert Tisch Brain Tumor Center (PRTBTC).
• Retrospective dates will be 3/1/06 through the approval date for the prospective component of this study.

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bivariate correlational analyses will be conducted to examine associations between neuropsychological, depression, demographic, medication data tumor-related treatment , and QoL variables.	5years

Secondary Outcome Measures

Name	Time	Method
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.	5 years

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States