GlioblastomaEXOFIELDSNCT06222138
Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma
A study testing The samples described below will be collected: in people with Glioblastoma, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This trial is a translational, open-label, monocentric prospective study of 80 patients aiming to study resistance mechanisms as well as biomarkers of resistance or sensitivity to TTFields. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- The samples described below will be collected:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2024to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥18 years at the time of study entry.
- Patient with newly diagnosed glioblastoma.
- Patient for which a treatment with radio-chemotherapy followed by TTFields has been decided and has not been started.
- Signed written informed consent.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- Patient affiliated to a Social Health Insurance in France.
Who cannot join
- Any condition contraindicated with sampling procedures required by the protocol.
- Any contraindication to the use of the medical device administering TTFields.
- Simultaneous participation in a therapeutic interventional clinical trial.
- Patient pregnant, or breast-feeding.
- Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
IUCT-O
Toulouse
Elizabeth COHEN-JONATHAN MOYAL, 05 31 15 54 45, moyal.elizabeth@iuct-oncopole.fr
About this study
This trial is a translational, open-label, monocentric prospective study of 80 patients aiming to study resistance mechanisms as well as biomarkers of resistance or sensitivity to TTFields.
The study will be conducted on a population of patients with newly diagnosed glioblastoma treated with radio-chemotherapy followed by TTFields in the context of either routine care or a clinical trial.
Read more
In this study, the Optune® system (battery operated device which delivers TTFields to the brain) will not be under investigation.
For each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable).
Moreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected.
Tumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure. No additional biopsies will be performed for the study.
Patients will be followed-up for time to progression and overall survival for a maximum duration of 24 months from the TTFields initiation.
MRI performed by patients during the course of the study will be collected by the sponsor for additional future research purposes.
- Conditions
- Glioblastoma
- Being tested
- The samples described below will be collected:
- Keywords
- Glioblastoma, Biologic tumor and plasma biomarkers, Translational research, TTFields
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The samples described below will be collected:Other
For each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable).
Moreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected.
Tumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Patients with newly diagnosed glioblastoma | Experimental | Not described Receives: Other: The samples described below will be collected: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) defined as the time from inclusion until death from any cause or last follow-up (censored data).
Measured: 27 months for each patient
Time to Progression (TTP) defined as the time from inclusion until progression. Patients without progression are censored at last follow-up.
Measured: 27 months for each patient
Secondary outcomes (1)
Number of patients with MRI collected.
Measured: 27 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start27 Aug 2024
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222138
- Sponsor's protocol ID
- 23 TETE 04
- Acronym
- EXOFIELDS
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT06222138
- Acronym / sponsor ID
- EXOFIELDS / 23 TETE 04
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Biologic tumor and plasma biomarkers, Translational research, TTFields
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- NovoCure Ltd.
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 24 Jan 2024 (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 trial is a translational, open-label, monocentric prospective study of 80 patients aiming to study resistance mechanisms as well as biomarkers of resistance or sensitivity to TTFields.
The study will be conducted on a population of patients with newly diagnosed glioblastoma treated with radio-chemotherapy followed by TTFields in the context of either routine care or a clinical trial.
In this study, the Optune® system (battery operated device which delivers TTFields to the brain) will not be under investigation.
For each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable).
Moreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected.
Tumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure. No additional biopsies will be performed for the study.
Patients will be followed-up for time to progression and overall survival for a maximum duration of 24 months from the TTFields initiation.
MRI performed by patients during the course of the study will be collected by the sponsor for additional future research purposes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with newly diagnosed glioblastoma | Experimental | Other: The samples described below will be collected: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years at the time of study entry.
- Patient with newly diagnosed glioblastoma.
- Patient for which a treatment with radio-chemotherapy followed by TTFields has been decided and has not been started.
- Signed written informed consent.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
Key exclusion criteria (7 listed)
- Any condition contraindicated with sampling procedures required by the protocol.
- Any contraindication to the use of the medical device administering TTFields.
- Simultaneous participation in a therapeutic interventional clinical trial.
- Patient pregnant, or breast-feeding.
- Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
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 |
|---|---|---|
| The samples described below will be collected:For each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable). Moreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected. Tumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure. | Other | Patients with newly diagnosed glioblastoma |
Primary outcome
Overall Survival (OS) defined as the time from inclusion until death from any cause or last follow-up (censored data).
Time frame: 27 months for each patient
Time to Progression (TTP) defined as the time from inclusion until progression. Patients without progression are censored at last follow-up.
Time frame: 27 months for each patient
1 secondary outcome
Number of patients with MRI collected.
Time frame: 27 months for each patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The samples described below will be collected: in people with Glioblastoma, run by Institut Claudius Regaud at 1 site in France.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Feb 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth COHEN-JONATHAN MOYAL (05 31 15 54 45, moyal.elizabeth@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) defined as the time from inclusion until death from any cause or last follow-up (censored data). (time frame: 27 months for each patient). The study lists 2 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 13 Feb 2026.