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Florida Center for Brain Tumor Research (FCBTR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00811148
Recruitment Status : Recruiting
First Posted : December 18, 2008
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date December 17, 2008
First Posted Date December 18, 2008
Last Update Posted Date August 2, 2019
Study Start Date March 2006
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2008)
Collect and maintain clinical data and tumor tissue removed during brain surgeries. [ Time Frame: 10 Years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00811148 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Florida Center for Brain Tumor Research
Official Title Establishment of a UF Brain Tumor Tissue Bank: Florida Center for Brain Tumor Research
Brief Summary The purpose of this research study is to collect and store brain tumor tissue samples for future research. The samples will become part of the University of Florida Brain Tumor Tissue Bank/Florida Center for Brain Tumor Research. The goal is to find improved treatments and cures for brain tumors.
Detailed Description

The mission of the Florida Center for Brain Tumor Research is to discover cures for brain tumors and develop innovative brain tumor treatment modalities by providing a central repository for brain tumor biopsies and clinical information from individuals throughout the state of Florida, improving brain tumor biomedical research programs within the state of Florida, facilitating funding opportunities, fostering collaboration with brain tumor research organizations and other institutions, and fostering improved technology transfer of brain tumor research findings into clinical trials and widespread public use.

The Florida Center for Brain Tumor Research will collect and store left-over tissue that is not needed for medical care or diagnosis in a tissue bank in the Evelyn F. and William L. McKnight Brain Institute at the University of Florida. Tissue, medical information, cerebrospinal fluid, blood and answers to Quality of Life questionnaires will be stored and made available to researchers. Although developed for Florida, tumor tissue from all other states would be accepted.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tissue, medical information, cerebrospinal fluid, blood and answers to Quality of Life questionnaires will be stored and made available to researchers.
Sampling Method Probability Sample
Study Population Children and adults scheduled to undergo brain surgery to remove tumor tissue.
Condition Brain Tumors
Intervention Procedure: Tissue Bank
Collection of clinical data and tumor tissue.
Study Groups/Cohorts Tissue Bank
Collection of clinical data and tumor tissue removed during brain surgeries for future research.
Intervention: Procedure: Tissue Bank
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 17, 2008)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children and adults scheduled to undergo brain surgery to remove tumor tissue.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Nina McGrew, MSN (352) 273-5519 nina.mcgrew@neurosurgery.ufl.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00811148
Other Study ID Numbers FCBTR
OCR13767 ( Other Identifier: OnCore )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor University of Florida
Collaborators Not Provided
Investigators
Principal Investigator: William A Friedman, MD University of Florida
PRS Account University of Florida
Verification Date July 2019