GRETeL: Tumor Response to Standard Radiotherapy and TMZ Patients With GBM
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.
Conditions:
🦠 Glioblastoma 🦠 Glioma, Malignant
🗓️ Study Start (Actual) 18 April 2023
🗓️ Primary Completion (Estimated) January 2029
✅ Study Completion (Estimated) January 2029
👥 Enrollment (Estimated) 100
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 December 2022
  • First Submitted that Met QC Criteria 20 January 2023
  • First Posted 25 January 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 April 2024
  • Last Update Posted 17 April 2024
  • Last Verified April 2024