Liquid Biopsy in Glioblastoma Treated With Chemoradiation and an Oxygen Therapeutic

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07417774

Acronym

RESTORE LB

Enrollment

Registered

2026-02-18

Start date

2025-12-08

Completion date

2030-12-01

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma (GBM)

Keywords

Glioblastoma, Liquid Biopsy

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Tumor hypoxia biomarkers	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

Measure	Time frame	Description
Biomarker expression	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	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.

Countries

United States

Outcome results