GRETeL: Tumor Response to Standard Radiotherapy and TMZ Patients With GBM (NCT05695976) | Clinical Trial Compass
SuspendedNot Applicable
GRETeL: Tumor Response to Standard Radiotherapy and TMZ Patients With GBM
Stopped: The study is suspended while preplanned interim analysis is being completed.
United States100 participantsStarted 2023-04-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'suspended' — can you find out why enrollment is paused and whether it's expected to resume, before we consider it as an option?
2This study seems to be focused on measuring cfDNA and ctDNA in the blood during and after radiation with TMZ, rather than testing a new treatment — does that mean participation wouldn't change my actual treatment plan, and what would I personally gain from joining?
3Since this trial is tracking DNA shed by the tumor into the bloodstream at specific time points, what does that involve practically — how many blood draws, and how would those appointments fit around my existing radiation schedule?
4This trial is labeled as 'Phase NA,' which suggests it's more of an observational or biomarker study than a standard treatment trial — can you help me understand whether this kind of study is the right priority right now compared to trials that might offer access to a new therapy?
5If the goal is to understand how ctDNA levels change in response to standard radiation and TMZ, would the data collected about my tumor actually be shared back with me or my care team in a way that could influence future treatment decisions?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Median cf/ctDNA concentration at pre- and post-radiation, as well as median change in ct/ctDNA concentration
Timeframe: 6 months
2
Median levels of cfDNA collected longitudinally after completion of radiation