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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44CA298498-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Tumor hypoxia biomarkers | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker expression | 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 |
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Inclusion Criteria:
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RESTORE study participants
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neurosciences | Tucson | Arizona | 85718 | United States | ||
| Yale Cancer Center |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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plasma
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 |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |