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Verified by Duke University, March 2009
First Received: March 30, 2009   Last Updated: March 31, 2009   History of Changes
Sponsor: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00873132
  Purpose

  1. 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.

  2. 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.
  3. 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.


Condition
Brain Tumor

Study Type: Observational
Study Design: Cohort
Official Title: BTC Neuropsychological Database:Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Depression
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Bivariate correlational analyses will be conducted to examine associations between neuropsychological, depression, demographic, medication data tumor-related treatment , and QoL variables. [ Time Frame: 5years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 5000
Study Start Date: April 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Data Collection
Collect data both retrospectively and prospectively on subjects seen at the Preston Robert Tisch Brain Tumor Center

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873132

Contacts
Contact: Bartolomew Brigidi, Ph.D. 919-684-3121 brigi002@mc.duke.edu
Contact: Renee Raynor, Ph.D. 919-684-1832 rayno013@mc.duke.edu

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

No publications provided

Responsible Party: Duke University Medical Center ( Bartholomew Brigidi,Ph.D. )
Study ID Numbers: 00012450
Study First Received: March 30, 2009
Last Updated: March 31, 2009
ClinicalTrials.gov Identifier: NCT00873132     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
 Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010



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