GRETeL: Tumor Response to Standard Radiotherapy and TMZ Patients With GBM

Study Overview
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Brief Summary
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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.

Official Title
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A Study for Patients Newly Diagnosed With Glioblastoma Being Treated With Standard Radiotherapy and Temozolomide (TMZ) to Evaluate Tumor Response Via Liquid Biopsies (GRETeL)

Conditions
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Glioblastoma, Glioma, Malignant

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients newly diagnosed with malignant glioma, IDH wildtype who have undergone surgical resection for their tumor and who are planned for standard of care radiation therapy with concurrent temozolomide (i.e., at least 59 Gy in 30 fractions over 6 weeks) Patients must have leftover tissue available from the surgical resection of their tumor available to request for this research. Able to undergo MRI of brain with and without contrast Signed informed consent approved by the Institutional Review Board (IRB) Exclusion Criteria: Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pilot<br>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<br>The remaining 80 patients accrued to this study (after the initial 20 patients accrue to the Pilot cohort). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Khasraw, Glioblastoma, Glioma, Pro00110247, GRETEL, Duke