Liquid Biopsy in Glioblastoma Treated With Chemoradiation and an Oxygen Therapeutic (RESTORE LB)

February 13, 2026 updated by: NuvOx LLC
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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85718
        • Center For Neurosciences
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

RESTORE study participants

Description

Inclusion Criteria:

  • Subjects must be enrolled in the RESTORE study (NCT03862430) and provide written informed consent for the RESTORE LB sub-study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
until disease progression and up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker expression
Time Frame: until disease progression and up to 5 years
To measure differentially expressed biomarkers that distinguish pseudoprogression from true progression
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
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.
until disease progression and up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NuvOx LLC

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESTORE LB
  • 1R44CA298498-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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