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.
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
40
Center for Neurosciences
Tucson, Arizona, United States
Yale Cancer Center
New Haven, Connecticut, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Tumor hypoxia biomarkers
Identify differentially expressed tumor hypoxia markers in newly-diagnosed glioblastoma subjects treated with NanO2 versus placebo in the RESTORE study.
Time frame: until disease progression and up to 5 years
Biomarker expression
To measure differentially expressed biomarkers that distinguish pseudoprogression from true progression
Time frame: 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.
Time frame: until disease progression and up to 5 years
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