NCT00873132

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

March 30, 2009

Last Update Submit

June 17, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

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

    5years

Secondary Outcomes (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.

    5 years

Study Arms (1)

Data Collection

Collect data both retrospectively and prospectively on subjects seen at the Preston Robert Tisch Brain Tumor Center

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Renee Raynor, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2009

First Posted

April 1, 2009

Study Start

April 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations