NCT00592865

Brief Summary

Study Objective: Brain tumors are poorly understood. The purpose of this research is to examine whether factors in lifestyle play a role in brain tumor development. The study will also investigate the contribution of inherited susceptibility to the risk of brain cancer. By gaining a better understanding of these influences, the investigators hope to learn how to prevent brain tumors in future generations, and to develop more effective strategies for treatment. Study Protocol: This is a case-control investigation. Persons affected with a brain tumor are compared to unaffected persons on previous medical history, diet and other factors. Those enrolled in the study will participate in an interview on general background, diet, medical history and lifestyle, and will provide a sample of DNA, clippings of your toenails, and a tap water sample from your home. All procedures are performed in the clinic or through the mail. 'Cases': Cases eligible for the study are persons with a recent diagnosis of a primary brain tumor (glioma or meningioma), at least 18 years of age. 'Controls': Controls in the study are non-family members of patients, similar in age and of the same gender. Suitable controls include in-laws, friends, neighbors and co-workers.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
terminated

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

Study Start

First participant enrolled

October 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

11.3 years

First QC Date

January 7, 2008

Last Update Submit

February 18, 2021

Conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

"Case" subjects will be identified from the patients referred to neurology/neurosurgery clinics. Cases, when enrolled in the study, will be asked to identify potential "controls" by providing the name and phone number of the same-sex in-law nearest in age to the case and/or the name of a same-sex friend will also be sought.

You may qualify if:

  • Case: Incident primary glioma or meningioma of any stage, diagnosed within 4 months.
  • Control: non-blood relative, friend, co-worker of same gender as case
  • Aged 18 and older; either gender; any race

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Kentuckaina Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Vanderbilt University Medical Center, Department of Neurological Surgery

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Mouthwash and salvia samples. Toenail samples are also collected.

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kathleen M. Egan, DSc

    H. Lee Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR
  • Reid C. Thompson, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
  • Renato V. LaRocca, MD

    Kentuckiana Cancer Center

    PRINCIPAL INVESTIGATOR
  • Jeffrey Olson, MD

    Emory University

    PRINCIPAL INVESTIGATOR
  • Burt Nabors, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Chair and Professor, Neurological Surgery

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 14, 2008

Study Start

October 1, 2003

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations