GlioblastomaNCT03194971
NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy
An observational study of Glioblastoma, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study will assess whole brain samples from glioblastoma patients at autopsy to determine the underlying pathological signatures of tumor treatment fields at autopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Tumor samples from patients treated with TTFields at initial diagnosis. and Tumor samples from patients treated with TTFields at tumor recurrence.
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 4 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Newly Diagnosed Glioblastoma Patients undergoing standard of care treatment consisting of surgery followed by chemo-radiation therapy will have the addition of Optune TTField therapy together with adjuvant chemotherapy. OR Recurrent Glioblastoma Patients with glioblastoma tumor recurrence defined by either imaging criteria, or deteriorating neurological function will be offered Optune TTField treatment at the discretion of the neurooncologist.
Who may be able to join
- Newly diagnosed glioblastoma, World Health Organization (WHO) grade IV, patients undergoing TTField therapy.
- Recurrent glioblastoma WHO grade IV, patients undergoing TTField therapy.
Who cannot join
- TTField compliance < 75%.
- Any contraindication to Optune TTField treatment.
- Initial brain tumor diagnosis < WHO grade IV.
- Duration of TTField therapy < 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
This study will assess whole brain samples from glioblastoma patients at autopsy to determine the underlying pathological signatures of tumor treatment fields at autopsy.
Read the detailed description
RATIONALE:
Optune therapy with tumor treatment fields (TTFields) has recently been FDA approved for the treatment of newly diagnosed glioblastoma due to a recent clinical trial that showed improvement in progression free survival and overall survival compared to standard therapy. (1) TTFields also have a role in the recurrent glioblastoma treatment where it has demonstrated equal efficacy to second-line chemotherapy also has been shown to tumor progression and improve overall survival.(2) Though preclinical studies are ongoing, glioblastoma patients who have undergone TTField therapy have not yet been assessed at autopsy to determine both the pathological signature of TTField treatment, and the pattern of failure. This study will determine how the underlying pathological signatures of tumors treated with TTFields differ from those naïve to TTFields by comparing tumor tissue at autopsy.
STUDY:
All patients undergoing TTField therapy for newly diagnosed and recurrent glioblastoma will be considered for inclusion for this study. The investigators expect to enroll five patients per year for four years, totaling 10 patients treated upfront and 10 patients treated at tumor recurrence. An objective of this study is to determine differences in the pathological pattern of failure when patients are treated with TTFields at initial diagnosis (up-front) compared to those treated at tumor recurrence.
- Conditions
- Glioblastoma
- Being tested
- Tumor samples from patients treated with TTFields at initial diagnosis., Tumor samples from patients treated with TTFields at tumor recurrence.
- Keywords
- glioblastoma, brain tumor autopsy, autopsy, Optune therapy, tumor treatment fields, TTFields, Recurrent glioblastoma, grade IV, brain tumor, newly diagnosed glioblastoma
- 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.
Tumor samples from patients treated with TTFields at initial diagnosis.Other
Pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed. Each metric will be statistically compared between groups.
Tumor samples from patients treated with TTFields at tumor recurrence.Device
Pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed. Each metric will be statistically compared between groups.
| Study group | Role | What they receive |
|---|---|---|
| TTField at Recurrence | Not described Receives: Device: Tumor samples from patients treated with TTFields at tumor recurrence. | |
| TTField at New Diagnosis | Not described Receives: Other: Tumor samples from patients treated with TTFields at initial diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mitotically active cells
Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of active cells will be counted computationally.
Measured: At baseline
Number of mitotically inactive cells
Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of not active cells will be counted computationally.
Measured: At baseline
Mitotic Ratio
Number of mitotically active cells divided by the number of not mitotically active cells per patient will be calculated.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Jun 2017
- Primary completion4 Jun 2023
- Study completion4 Jun 2023
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 Medical College of WisconsinThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter LaViolette, Medical College of Wisconsin
- Investigators
- Peter LaViolette, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194971
- Sponsor's protocol ID
- PRO00017446
- Status last verified
- Mar 2026
- First submitted
- 12 Jun 2017
- Last updated
- 30 Mar 2026
- 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy
- ClinicalTrials.gov ID
- NCT03194971
- Acronym / sponsor ID
- PRO00017446
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, brain tumor autopsy, autopsy, Optune therapy, tumor treatment fields, TTFields, Recurrent glioblastoma, grade IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 4 Jun 2023 (actual)
- First posted
- 21 Jun 2017 (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.
This study will assess whole brain samples from glioblastoma patients at autopsy to determine the underlying pathological signatures of tumor treatment fields at autopsy.
Detailed description
RATIONALE:
Optune therapy with tumor treatment fields (TTFields) has recently been FDA approved for the treatment of newly diagnosed glioblastoma due to a recent clinical trial that showed improvement in progression free survival and overall survival compared to standard therapy. (1) TTFields also have a role in the recurrent glioblastoma treatment where it has demonstrated equal efficacy to second-line chemotherapy also has been shown to tumor progression and improve overall survival.(2) Though preclinical studies are ongoing, glioblastoma patients who have undergone TTField therapy have not yet been assessed at autopsy to determine both the pathological signature of TTField treatment, and the pattern of failure. This study will determine how the underlying pathological signatures of tumors treated with TTFields differ from those naïve to TTFields by comparing tumor tissue at autopsy.
STUDY:
All patients undergoing TTField therapy for newly diagnosed and recurrent glioblastoma will be considered for inclusion for this study. The investigators expect to enroll five patients per year for four years, totaling 10 patients treated upfront and 10 patients treated at tumor recurrence. An objective of this study is to determine differences in the pathological pattern of failure when patients are treated with TTFields at initial diagnosis (up-front) compared to those treated at tumor recurrence.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TTField at Recurrence | – | Device: Tumor samples from patients treated with TTFields at tumor recurrence. |
| TTField at New Diagnosis | – | Other: Tumor samples from patients treated with TTFields at initial diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly Diagnosed Glioblastoma Patients undergoing standard of care treatment consisting of surgery followed by chemo-radiation therapy will have the addition of Optune TTField therapy together with adjuvant chemotherapy. OR Recurrent Glioblastoma Patients with glioblastoma tumor recurrence defined by either imaging criteria, or deteriorating neurological function will be offered Optune TTField treatment at the discretion of the neurooncologist.
Key inclusion criteria (2 listed)
- Newly diagnosed glioblastoma, World Health Organization (WHO) grade IV, patients undergoing TTField therapy.
- Recurrent glioblastoma WHO grade IV, patients undergoing TTField therapy.
Key exclusion criteria (4 listed)
- TTField compliance < 75%.
- Any contraindication to Optune TTField treatment.
- Initial brain tumor diagnosis < WHO grade IV.
- Duration of TTField therapy < 3 months.
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 |
|---|---|---|
| Tumor samples from patients treated with TTFields at initial diagnosis.Pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed. Each metric will be statistically compared between groups. | Other | TTField at New Diagnosis |
| Tumor samples from patients treated with TTFields at tumor recurrence.Pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed. Each metric will be statistically compared between groups. | Device | TTField at Recurrence |
Primary outcome
Number of mitotically active cells
Time frame: At baseline
Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of active cells will be counted computationally.
Number of mitotically inactive cells
Time frame: At baseline
Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of not active cells will be counted computationally.
Mitotic Ratio
Time frame: At baseline
Number of mitotically active cells divided by the number of not mitotically active cells per patient will be calculated.
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 30 Mar 2026.
- 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.
Peter LaViolette, PhD principal investigator
Medical College of Wisconsin
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 Medical College of Wisconsin 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 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: finished, as of the sponsor's last update on 30 Mar 2026. 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?
Number of mitotically active cells (time frame: At baseline). The study lists 3 primary outcomes in all. 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 30 Mar 2026.