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Enrolling by invitation NCT07417774

Liquid Biopsy in Glioblastoma Treated With Chemoradiation and an Oxygen Therapeutic

— Observational Glioblastoma (GBM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Glioblastoma (GBM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Tumor hypoxia biomarkers [Time frame: until disease progression and up to 5 years]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • Center for Neurosciences — Tucson
  • Yale Cancer Center — New Haven
  • Saint Luke's Cancer Institute — Kansas City
  • Duke University Medical Center — Durham

Identifiers

NCT: NCT07417774 · RESTORE LB · 1R44CA298498-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗