Glioblastoma (GBM)RESTORE LBNCT07417774
Liquid Biopsy in Glioblastoma Treated With Chemoradiation and an Oxygen Therapeutic
An observational study of Glioblastoma (GBM), run by NuvOx LLC at 4 sites in United States.
Trial summary
The goal of this sub-study of the RESTORE trial is to identify biomarkers associated with tumor hypoxia, identify biomarkers that differentiate pseudoprogression from true progression, and correlate biomarkers with clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma (GBM)
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Dec 2025to Dec 2030
- Phase
- Observational
- 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
Study population: RESTORE study participants
Who may be able to join
- Subjects must be enrolled in the RESTORE study (NCT03862430) and provide written informed consent for the RESTORE LB sub-study
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Duke University Medical Center
Durham, North Carolina, 27710
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Yale Cancer Center
New Haven, Connecticut, 06520
Center for Neurosciences
Tucson, Arizona, 85718
About this study
The goal of this sub-study of the RESTORE trial is to identify biomarkers associated with tumor hypoxia, identify biomarkers that differentiate pseudoprogression from true progression, and correlate biomarkers with clinical outcomes.
Read the detailed description
Blood samples for liquid biopsy will be collected at the same time as the scheduled blood draws in the RESTORE study and analyzed by FYR Diagnostics.
- Conditions
- Glioblastoma (GBM)
- Keywords
- Glioblastoma, Liquid Biopsy
- Medical subject headings
- Glioblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor hypoxia biomarkers
Identify differentially expressed tumor hypoxia markers in newly-diagnosed glioblastoma subjects treated with NanO2 versus placebo in the RESTORE study.
Measured: until disease progression and up to 5 years
Secondary outcomes (2)
Biomarker expression
To measure differentially expressed biomarkers that distinguish pseudoprogression from true progression
Measured: until disease progression and up to 5 years
Relationship between biomarker levels, MGMT methylation status, and survival outcomes
Evaluate whether biomarker levels are associated with MGMT promoter methylation status and how long study participants live without their disease getting worse (Progression-Free Survival) and how long they live overall (Overall Survival). This will help determine whether the biomarkers may predict patient outcomes.
Measured: until disease progression and up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start8 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuvOx LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417774
- Sponsor's protocol ID
- RESTORE LB
- Other IDs
- 1R44CA298498-01A1
- Acronym
- RESTORE LB
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy in Glioblastoma Treated With Chemoradiation and an Oxygen Therapeutic
- ClinicalTrials.gov ID
- NCT07417774
- Acronym / sponsor ID
- RESTORE LB / RESTORE LB
- Conditions
- Glioblastoma (GBM)
- Keywords
- Glioblastoma, Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NuvOx LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Feb 2026 (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 goal of this sub-study of the RESTORE trial is to identify biomarkers associated with tumor hypoxia, identify biomarkers that differentiate pseudoprogression from true progression, and correlate biomarkers with clinical outcomes.
Detailed description
Blood samples for liquid biopsy will be collected at the same time as the scheduled blood draws in the RESTORE study and analyzed by FYR Diagnostics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RESTORE study participants
Key inclusion criteria (1 listed)
- Subjects must be enrolled in the RESTORE study (NCT03862430) and provide written informed consent for the RESTORE LB sub-study
Key exclusion criteria (0 listed)
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
Tumor hypoxia biomarkers
Time frame: until disease progression and up to 5 years
Identify differentially expressed tumor hypoxia markers in newly-diagnosed glioblastoma subjects treated with NanO2 versus placebo in the RESTORE study.
2 secondary outcomes
Biomarker expression
Time frame: until disease progression and up to 5 years
Relationship between biomarker levels, MGMT methylation status, and survival outcomes
Time frame: until disease progression and up to 5 years
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 18 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma (GBM), run by NuvOx LLC at 4 sites 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 1 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 18 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 4 sites 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?
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?
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?
Tumor hypoxia biomarkers (time frame: until disease progression and up to 5 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 18 Feb 2026.