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The study is suspended while preplanned interim analysis is being completed.
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| Name | Class |
|---|---|
| Personalis Inc. | INDUSTRY |
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The purpose of this study is to better define longitudinal genomic alterations in patients with glioblastoma (GBM), and to determine if plasma circulating tumor DNA (ctDNA) or cell free DNA (cfDNA) is associated with disease recurrence, survival, tumor characteristics, and/or peripheral immunosuppression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot | The first 20 patients accrued to this study will be assayed to validate the performance of the assays developed by Personalis. This pilot sub-study will be analyzed in a "blinded" manner without clinical information. | ||
| Full Study | The remaining 80 patients accrued to this study (after the initial 20 patients accrue to the "Pilot" cohort). |
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| Measure | Description | Time Frame |
|---|---|---|
| Median cf/ctDNA concentration at pre- and post-radiation, as well as median change in ct/ctDNA concentration | Identify and describe changes in the cell free DNA (cfDNA) sequencing profiles of patients diagnosed with GBM in pre- versus post-radiation therapy samples, and to assess the association between these changes and clinical outcome, including progression free and overall survival | 6 months |
| Median levels of cfDNA collected longitudinally after completion of radiation | Identify and describe changes over time after radiotherapy in the cfDNA sequencing profiles of patients diagnosed with GBM, and to assess the association between these longitudinal changes in cfDNA and clinical outcome, including progression free and overall survival | 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Characterize the fragmentomic landscape of GBM | Median number of ctDNA fragments obtained from tumor tissue, pre-radiation serum specimen, and post-radiation serum specimen, and healthy controls. | 6 months |
| Spearman correlation between clinical descriptors and measures of ctDNA |
Inclusion Criteria:
Exclusion Criteria:
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Patients newly diagnosed with glioblastoma post-resection who are scheduled to receive standard radiation and chemotherapy (temozolomide).
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| Name | Affiliation | Role |
|---|---|---|
| Mustafa Khasraw, MBChB, MD, FRCP, FRACP | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Preston Robert Tisch Brain Tumor Center at Duke University | Durham | North Carolina | 27710 | United States |
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| Label | URL |
|---|---|
| The Preston Robert Tisch Brain Center at Duke University | View source |
| Duke Health | View source |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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Tumor (archival) specimens will be obtained from the surgical resection and diagnosis of GBM and before initiation of radiotherapy. It is anticipated that a certain proportion of patients will need to undergo further tumor debulking after radiotherapy. In such instances, these post-radiotherapy re-resected tumor specimens will also be collected for later sequencing.
Assess the association between degree and frequency of ctDNA shedding and clinical characteristics, such as molecular findings, histopathological characteristics, corticosteroid use, and bevacizumab use. |
| 6 months |
| Median and range for measures of tumor immune infiltration | Quantify the level of immune infiltration in the tumor, and assess its association with progression-free survival (PFS), overall survival (OS), and ctDNA detection. | 6 months |
| Hazard ratio for the relationship between chromosomal instability and OS or PFS | Assess the prognostic value of chromosomal instability/CAN burden, and assess its association with ctDNA from plasma. | 6 months |
| Spearman correlation between ctDNA and peripheral T cell function, autoantibodies. | Determine if peripheral T cell function and stemness or autoantibodies are association with ctDNA levels, or TME composition. | 6 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |