GlioblastomaNCT03403803
Prognosis and Therapeutic Biomarkers for Glioblastoma Patients
An observational study of Glioblastoma, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to investigate if the potential biomarkers identified could be used for facilitating the diagnosis and prognosis of patients with glioblastoma (GBM). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Optune
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 25 Mar 2019
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with GBM or diagnosed with other neurological disorder that requires a lumbar puncture.
Who may be able to join
- 22 years old
- Control Group (only patients evaluated for neurological disorders whose evaluation require a lumbar puncture)
- Non-Control Group - Diagnosed with GBM (Glioblastoma)
Who cannot join
- Pregnancy
- Infectious Disease to include cold, flu, HIV, etc.
- Blood Disorder (example:low platelets, anemia, thrombosis)
- Vascular Malformations
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott and White Medical Center
Temple, Texas, 76508
About this study
The purpose of this study is to investigate if the potential biomarkers identified could be used for facilitating the diagnosis and prognosis of patients with glioblastoma (GBM).
Read the detailed description
The objective of this proposed study is to determine the expression levels of a panel of markers including CD133, CD44, ABCC3, TNFRSF1A, AKT1, IDH2, and MGMT in GBM tissues and the CSF, blood, and saliva from patients with GBM receiving different types of treatment (Optune only or Optune with TMZ) and the non-brain tumor patients (controls). Our aims are: 1) To compare the differences of CD44 between the control group and the combined cancer groups at baseline; and 2) To compare the levels of CD44 and other markers among the 3 different groups such as control vs. GBM patients and Optune vs. Optune + TMZ after 8 weeks of treatment. Exploratory analysis of all other markers will be performed.
- Conditions
- Glioblastoma
- Being tested
- Optune
- Keywords
- Glioblastoma, Brain Tumor
- 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.
OptuneDevice
Also called TMZ
Optune is a wearable and portable, FDA-approved device that has been shown in clinical trials to safely deliver continuous therapy to the area of your brain where your GBM (Glioblastoma) tumor is located.
TMZ (Temozolomide) is an oral chemotherapy drug. It is an alkylating agent used as a treatment of some brain cancers; as a second-line treatment for astrocytoma and a first-line treatment for glioblastoma multiforme.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Not described | |
| Optune Only | Not described Receives: Device: Optune | |
| Optune and TMZ | Not described Receives: Device: Optune |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome - CD44 expression in cerebrospinal fluid (CSF), blood and saliva
Currently, Glioblastoma is only diagnosed and monitored with brain scans. Expression levels of CD44 along with CD133, ABCC3, TNFRSF1A, AKT1, IDH2 and MGMT in samples of CSF, blood and saliva from patients receiving different types of treatment and comparing them with non-GBM patients (control group) will be tested.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Sep 2017
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Why it stopped: Were not able to meet enrollment goal due to inclusion/exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ekokobe Fonkem, MD, Principal investigator, Baylor Scott and White Medical Center, Temple, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403803
- Sponsor's protocol ID
- 160280
- Status last verified
- Mar 2019
- First submitted
- 9 Nov 2017
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Therapeutic Biomarkers for Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT03403803
- Acronym / sponsor ID
- 160280
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Brain Tumor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Were not able to meet enrollment goal due to inclusion/exclusion criteria
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 19 Jan 2018 (actual)
- 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 investigate if the potential biomarkers identified could be used for facilitating the diagnosis and prognosis of patients with glioblastoma (GBM).
Detailed description
The objective of this proposed study is to determine the expression levels of a panel of markers including CD133, CD44, ABCC3, TNFRSF1A, AKT1, IDH2, and MGMT in GBM tissues and the CSF, blood, and saliva from patients with GBM receiving different types of treatment (Optune only or Optune with TMZ) and the non-brain tumor patients (controls). Our aims are: 1) To compare the differences of CD44 between the control group and the combined cancer groups at baseline; and 2) To compare the levels of CD44 and other markers among the 3 different groups such as control vs. GBM patients and Optune vs. Optune + TMZ after 8 weeks of treatment. Exploratory analysis of all other markers will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | – |
| Optune Only | – | Device: Optune |
| Optune and TMZ | – | Device: Optune |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with GBM or diagnosed with other neurological disorder that requires a lumbar puncture.
Key inclusion criteria (3 listed)
- 22 years old
- Control Group (only patients evaluated for neurological disorders whose evaluation require a lumbar puncture)
- Non-Control Group - Diagnosed with GBM (Glioblastoma)
Key exclusion criteria (4 listed)
- Pregnancy
- Infectious Disease to include cold, flu, HIV, etc.
- Blood Disorder (example:low platelets, anemia, thrombosis)
- Vascular Malformations
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 |
|---|---|---|
| OptuneAlso: TMZOptune is a wearable and portable, FDA-approved device that has been shown in clinical trials to safely deliver continuous therapy to the area of your brain where your GBM (Glioblastoma) tumor is located. TMZ (Temozolomide) is an oral chemotherapy drug. It is an alkylating agent used as a treatment of some brain cancers; as a second-line treatment for astrocytoma and a first-line treatment for glioblastoma multiforme. | Device | Optune Only, Optune and TMZ |
Primary outcome
Primary Outcome - CD44 expression in cerebrospinal fluid (CSF), blood and saliva
Time frame: 2 years
Currently, Glioblastoma is only diagnosed and monitored with brain scans. Expression levels of CD44 along with CD133, ABCC3, TNFRSF1A, AKT1, IDH2 and MGMT in samples of CSF, blood and saliva from patients receiving different types of treatment and comparing them with non-GBM patients (control group) will be tested.
Results and safety
The study was stopped early (reason given: Were not able to meet enrollment goal due to inclusion/exclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
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Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
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RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
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PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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.
Ekokobe Fonkem, MD principal investigator
Baylor Scott and White Medical Center, Temple, TX
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, run by Baylor Research Institute 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 4 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 27 Mar 2019. 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 was stopped early (reason given: Were not able to meet enrollment goal due to inclusion/exclusion criteria). 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.
What does the primary outcome measure?
Primary Outcome - CD44 expression in cerebrospinal fluid (CSF), blood and saliva (time frame: 2 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 27 Mar 2019.