Glioblastoma MultiformeNCT01135875
Laboratory Study of Early Tumor Markers in the Peripheral Blood of Glioblastoma Multiforme Patients
An observational study of Glioblastoma Multiforme and Healthy Volunteers, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine if tumor cells can be detected in the blood of patients diagnosed with a brain tumor. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma Multiforme, Healthy Volunteers
- What is being tested?
- GBM Patients
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Apr 2013
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited during routine interactions with the investigators.
Who may be able to join
- 18 to 89 years of age
- Weight of at least 110 pounds
- Able to provide informed consent for self
Who cannot join
- Patients with active malignant tumors other than GBM
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Glioblastoma Multiforme (GBM) Circulating Tumor Cells (CTCs) as Early, Less Invasive Markers of Progression and Response
The purpose of this study is to determine if tumor cells can be detected in the blood of patients diagnosed with a brain tumor.
Read the detailed description
Despite aggressive therapies, Glioblastoma Multiforme (GBM) is rapidly fatal. GBMs are increasingly recognized for occasionally metastasizing through the peripheral blood to distant locations. This research study involves the detection and novel characterization of human GBM (hGBM) circulating tumor cells (CTCs) within the peripheral blood of brain tumor patients by identifying their unique cell surface antigen profile, determining an optimal isolation protocol, and quantitatively and qualitatively reporting the yield and characteristics.
- Conditions
- Glioblastoma Multiforme, Healthy Volunteers
- Being tested
- GBM Patients, Normal Controls
- Keywords
- GBM, Brain Tumor, Brain Neoplasm, Control, Normal Control, Volunteer
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBM PatientsOther
2 teaspoons of blood will be collected during select clinic visits.
Normal ControlsOther
2 teaspoons of blood will be collected once.
| Study group | Role | What they receive |
|---|---|---|
| GBM Patients | GBM Patients with a histologically confirmed or suspected diagnosis of glioblastoma multiforme. Receives: Other: GBM Patients | |
| Normal Controls | Normal Controls will be adult volunteers who identify themselves as not having been diagnosed with a glioblastoma multiforme. Receives: Other: Normal Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Human GBM CD Antigen Signature.
Already established and stored GBM cell lines will be screened for CD antigens to confirm that a selective cell surface antigen can be identified.
Measured: 3 Years
Secondary outcomes (3)
Identification & Isolation of Human GBM Cells in Seeded Normal Control Human Blood.
Frozen and fresh human blood will be seeded with human GBM cells from established stored GBM cell lines and subjected to antibody-based cell identification and isolation procedures.
Measured: 3 Years
Prospective Isolation of GBM Tumor Cells in GBM Patient Blood.
Circulating tumor cells will be isolated from blood drawn from GBM patients.
Measured: 3 Years
Prospective Evaluation of the Routine Medical History of GBM Patients.
Medical records of GBM patients will be used to determine how circulating tumor cells impact outcome.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brent Reynolds, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135875
- Sponsor's protocol ID
- CTC-01
- Status last verified
- Oct 2013
- First submitted
- 24 May 2010
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Glioblastoma Multiforme (GBM) Circulating Tumor Cells (CTCs) as Early, Less Invasive Markers of Progression and Response
- ClinicalTrials.gov ID
- NCT01135875
- Acronym / sponsor ID
- CTC-01
- Conditions
- Glioblastoma Multiforme, Healthy Volunteers
- Keywords
- GBM, Brain Tumor, Brain Neoplasm, Control, Normal Control, Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Jun 2010 (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.
The purpose of this study is to determine if tumor cells can be detected in the blood of patients diagnosed with a brain tumor.
Detailed description
Despite aggressive therapies, Glioblastoma Multiforme (GBM) is rapidly fatal. GBMs are increasingly recognized for occasionally metastasizing through the peripheral blood to distant locations. This research study involves the detection and novel characterization of human GBM (hGBM) circulating tumor cells (CTCs) within the peripheral blood of brain tumor patients by identifying their unique cell surface antigen profile, determining an optimal isolation protocol, and quantitatively and qualitatively reporting the yield and characteristics.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBM Patients | – | Other: GBM PatientsGBM Patients with a histologically confirmed or suspected diagnosis of glioblastoma multiforme. |
| Normal Controls | – | Other: Normal ControlsNormal Controls will be adult volunteers who identify themselves as not having been diagnosed with a glioblastoma multiforme. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited during routine interactions with the investigators.
Key inclusion criteria (3 listed)
- 18 to 89 years of age
- Weight of at least 110 pounds
- Able to provide informed consent for self
Key exclusion criteria (1 listed)
- Patients with active malignant tumors other than GBM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBM Patients2 teaspoons of blood will be collected during select clinic visits. | Other | GBM Patients |
| Normal Controls2 teaspoons of blood will be collected once. | Other | Normal Controls |
Primary outcome
Identification of Human GBM CD Antigen Signature.
Time frame: 3 Years
Already established and stored GBM cell lines will be screened for CD antigens to confirm that a selective cell surface antigen can be identified.
3 secondary outcomes
Identification & Isolation of Human GBM Cells in Seeded Normal Control Human Blood.
Time frame: 3 Years
Prospective Isolation of GBM Tumor Cells in GBM Patient Blood.
Time frame: 3 Years
Prospective Evaluation of the Routine Medical History of GBM Patients.
Time frame: 3 Years
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 17 Oct 2013.
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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.
Brent Reynolds, PhD principal investigator
University of Florida
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 Glioblastoma Multiforme and Healthy Volunteers, run by University of Florida 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 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: finished, as of the sponsor's last update on 17 Oct 2013. 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?
Identification of Human GBM CD Antigen Signature. (time frame: 3 Years). 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 17 Oct 2013.