Brain DiseasesNCT00592709
Analysis of Brain Tumors Using Matrix Assisted Laser Desorption/Ionization Mass Spectrometry
An observational study of Brain Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
We are collecting brain tissue specimens and blood samples from patients at Vanderbilt University Medical Center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. Read more about this study
- Who is it for?
- Ages 2 to 85 years
- Conditions the study is for
- Brain Diseases
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Dec 2012
- 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 2 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Age 2 years through Age 85 years old
Who may be able to join
- A diagnosis of brain tumor or other non-cancerous tissue and are considered candidates fro a surgical procedure to biopsy or remove the brain tumor or other tissue type at Vanderbilt University Medical Center.
- Age 2 to 85
Who cannot join
- Patient or guardian that is unable to understand the informed consent process.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center, Department of Neurological Surgery
Nashville, Tennessee, 37232
About this study
We are collecting brain tissue specimens and blood samples from patients at Vanderbilt University Medical Center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. These specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis, looking for unique protein signatures.
Read the detailed description
We are collecting brain tissue specimens and blood samples from patients at Vanderbilt University Medical Center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. These specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis. Data from different brain tissues including tumors of different histological sub-types will be analyzed for unique protein signatures. These protein signatures will then be statistically correlated with clinical data including time to tumor progression and response to therapy.
The goal of this study is to determine molecular patterns that will be more predictive of tumor behavior, thus leading to an improved understanding of the basic biology of these poorly understood cancers. This in turn, may lead to more refined therapies and improved outcomes.
- Conditions
- Brain Diseases
- Medical subject headings
- Brain Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of proteomic signatures in brain tumor samples
measurement of proteomic signatures in brain tumor samples for unique protein signatures
Measured: immediately upon analysis of the sample
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 startMay 2003
- Primary completionDec 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies 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
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reid Thompson, Vanderbilt University Medical Center
- Investigators
- Reid C. Thompson, MD, Principal investigator, Vanderbilt University Medical Center, Department of Neurological Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592709
- Sponsor's protocol ID
- 030258
- Status last verified
- Feb 2021
- First submitted
- 2 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
- Analysis of Brain Tumors Using Matrix Assisted Laser Desorption/Ionization Mass Spectrometry
- ClinicalTrials.gov ID
- NCT00592709
- Acronym / sponsor ID
- 030258
- Conditions
- Brain Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (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.
We are collecting brain tissue specimens and blood samples from patients at Vanderbilt University Medical Center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. These specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis, looking for unique protein signatures.
Detailed description
We are collecting brain tissue specimens and blood samples from patients at Vanderbilt University Medical Center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. These specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis. Data from different brain tissues including tumors of different histological sub-types will be analyzed for unique protein signatures. These protein signatures will then be statistically correlated with clinical data including time to tumor progression and response to therapy.
The goal of this study is to determine molecular patterns that will be more predictive of tumor behavior, thus leading to an improved understanding of the basic biology of these poorly understood cancers. This in turn, may lead to more refined therapies and improved outcomes.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Age 2 years through Age 85 years old
Key inclusion criteria (2 listed)
- A diagnosis of brain tumor or other non-cancerous tissue and are considered candidates fro a surgical procedure to biopsy or remove the brain tumor or other tissue type at Vanderbilt University Medical Center.
- Age 2 to 85
Key exclusion criteria (1 listed)
- Patient or guardian that is unable to understand the informed consent process.
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
Measurement of proteomic signatures in brain tumor samples
Time frame: immediately upon analysis of the sample
measurement of proteomic signatures in brain tumor samples for unique protein signatures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Reid C. Thompson, MD principal investigator
Vanderbilt University Medical Center, Department of Neurological Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Diseases, run by Vanderbilt University Medical Center at 1 site 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 2 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: finished, 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 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Measurement of proteomic signatures in brain tumor samples (time frame: immediately upon analysis of the sample). It is what the study was designed to measure, not a finding.
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.