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

Suspended

• Conditions: Glioblastoma; Glioma, Malignant

• Registration Number: NCT05695976
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-25
• Study Start: 2023-04-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median levels of cfDNA collected longitudinally after completion of radiation	6 months	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
Median cf/ctDNA concentration at pre- and post-radiation, as well as median change in ct/ctDNA concentration	6 months	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

Trial Locations

Locations (1)

The Preston Robert Tisch Brain Tumor Center at Duke University; 🇺🇸 Durham, North Carolina, United States