Liquid Biopsy in Glioblastoma Treated With Chemoradiation and an Oxygen Therapeutic

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.

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Key information

Conditions

Glioblastoma (GBM) Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Neurosciences, Tucson, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Biomarker expression

Time frame: until disease progression and up to 5 years

To measure differentially expressed biomarkers that distinguish pseudoprogression from true progression
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.

Sponsors and collaborators

Lead sponsor

NuvOx LLC

Industry

Collaborators

National Cancer Institute (NCI)

Registry information

Acronym: RESTORE LB

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2030
First posted: Feb 18, 2026
Registry last updated: Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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