Brain Neoplasm, PrimaryNCT00592865
Risk Factors for Adult-Onset Brain Tumors
An observational study of Brain Neoplasm, Primary and Brain Neoplasms, Malignant, run by Vanderbilt University Medical Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Neoplasm, Primary, Brain Neoplasms, Malignant, Brain Neoplasms, Benign
- How many people
- 850 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2003to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Kentuckaina Cancer Institute
Louisville, Kentucky, 40202
Vanderbilt University Medical Center, Department of Neurological Surgery
Nashville, Tennessee, 37232
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Genetic Epidemiology of Adult Brain Tumors
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.
Read more
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.
Read the detailed description
Primary Objective:
The primary objective of this research is to establish a clinic-based case-control study for examination of potential risk factors for primary adult brain tumors. After assembling a series of 1,500 cases and 3,000 controls, investigators will test current hypotheses on ge-netic and environmental risk factors for the occurrence of these tumors.
STUDY DESIGN:
In this case-control study, persons with a recent diagnosis (within 4 months) of a primary brain tumor will be identified in the neurology/neurosurgery clinics at major treatment referral centers in the Southeast. Non-blood related relatives (eg. in-laws), friends or other persons will be recruited as controls. Names and contact information of eligible controls will be ascertained from patients. A total of 1,500 cases and 3,000 controls will be enrolled over the course of the 5-year study. All enrolled subjects will complete a one hour interview on lifestyle, environmental exposures, diet, physical activity, tobacco use and medical history. They will also be asked to provide a DNA sample, a water sample and a toenail sample (from each great toe). At the end of data collection, lifestyles and genetic attributes will be compared in cases and controls to identify any differences that may be relevant to the causation of disease. Because the study will recruit patients near the time of disease diagnosis, full enrollment should be possible. In addition, high re-sponse rates are anticipated among the controls. Thus, with the large numbers of patients available and high anticipated response rates, the study offers a unique opportunity to successfully identify environmental and genetic risk factors for this uncommon form of cancer.
- Medical subject headings
- Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startOct 2003
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Neoplasm, PrimaryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute, Kentuckiana Cancer Institute, Emory University, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Reid Thompson, Vanderbilt University Medical Center
- Investigators
- Kathleen M. Egan, DSc, Principal investigator, H. Lee Moffitt Cancer CenterReid C. Thompson, MD, Principal investigator, Vanderbilt University Medical CenterRenato V. LaRocca, MD, Principal investigator, Kentuckiana Cancer CenterJeffrey Olson, MD, Principal investigator, Emory UniversityBurt Nabors, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592865
- Sponsor's protocol ID
- 030917
- Status last verified
- Feb 2021
- First submitted
- 7 Jan 2008
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiology of Adult Brain Tumors
- ClinicalTrials.gov ID
- NCT00592865
- Acronym / sponsor ID
- 030917
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute, Kentuckiana Cancer Institute, Emory University, University of Alabama at Birmingham
- Study start
- Oct 2003
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
The primary objective of this research is to establish a clinic-based case-control study for examination of potential risk factors for primary adult brain tumors. After assembling a series of 1,500 cases and 3,000 controls, investigators will test current hypotheses on ge-netic and environmental risk factors for the occurrence of these tumors.
STUDY DESIGN:
In this case-control study, persons with a recent diagnosis (within 4 months) of a primary brain tumor will be identified in the neurology/neurosurgery clinics at major treatment referral centers in the Southeast. Non-blood related relatives (eg. in-laws), friends or other persons will be recruited as controls. Names and contact information of eligible controls will be ascertained from patients. A total of 1,500 cases and 3,000 controls will be enrolled over the course of the 5-year study. All enrolled subjects will complete a one hour interview on lifestyle, environmental exposures, diet, physical activity, tobacco use and medical history. They will also be asked to provide a DNA sample, a water sample and a toenail sample (from each great toe). At the end of data collection, lifestyles and genetic attributes will be compared in cases and controls to identify any differences that may be relevant to the causation of disease. Because the study will recruit patients near the time of disease diagnosis, full enrollment should be possible. In addition, high re-sponse rates are anticipated among the controls. Thus, with the large numbers of patients available and high anticipated response rates, the study offers a unique opportunity to successfully identify environmental and genetic risk factors for this uncommon form of cancer.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M. Egan, DSc principal investigator
H. Lee Moffitt Cancer Center
Reid C. Thompson, MD principal investigator
Vanderbilt University Medical Center
Renato V. LaRocca, MD principal investigator
Kentuckiana Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasm, Primary and Brain Neoplasms, Malignant, run by Vanderbilt University Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.