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BTC Neuropsychological Database

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00873132
Recruitment Status : Withdrawn (No Funding)
First Posted : April 1, 2009
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Brain Tumor

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.


Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Official Title: BTC Neuropsychological Database:Prospective Study
Study Start Date : April 2009
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Data Collection
Collect data both retrospectively and prospectively on subjects seen at the Preston Robert Tisch Brain Tumor Center


Outcome Measures

Primary Outcome Measures :
  1. Bivariate correlational analyses will be conducted to examine associations between neuropsychological, depression, demographic, medication data tumor-related treatment , and QoL variables. [ Time Frame: 5years ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873132


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Renee Raynor, Ph.D. Duke University
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00873132     History of Changes
Other Study ID Numbers: Pro00012450
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013