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

Duke University

Status: Suspended

Conditions: Glioblastoma; Glioma, Malignant

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05695976

Pro00110247

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Pilot

Description:

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

Description:

The remaining 80 patients accrued to this study (after the initial 20 patients accrue to the "Pilot" cohort).