United States, Australia, Canada350 participantsStarted 2024-08-02
Plain-language summary
The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.
Who can participate
Age range
12 Months – 39 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: Patients must be ≥12 months and ≤39 years of age at the time of enrollment onto this screening protocol.
. Diagnosis: Patients with newly diagnosed HGG, including DIPG are eligible. Diagnosis must have histologic confirmation from biopsy or resection. The diagnosis of HGG must have been confirmed by pathology review at the local site. For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology consistent with diffuse WHO grade 2-4 glioma (eg, diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered diffuse midline glioma). For all other tumors, histologic grade must be WHO grade 3-4.
. Disease Status: There are no disease status requirements for enrollment.
. Prior Therapy for HGG: Surgery, radiation, and/or dexamethasone are permissible. Temozolomide concurrent with radiation is permissible. Prior administration of avastin/bevacizumab is allowed (individual treatment arms have different washout period requirements, check individual arm eligibility). No other prior anticancer therapy for HGG will be allowed.
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.
1Since this trial focuses on molecular profiling rather than testing a specific drug, can you help me understand whether the goal right now is just to analyze my child's tumor genetics to see if they'd qualify for a targeted treatment later — and what happens after that profiling is done?
2This trial is listed as 'Phase NA,' which suggests it may be more of a screening or registry-type study than a traditional treatment trial — does that mean my child would still receive standard care while their tumor is being profiled, and nothing experimental would be given through this particular study?
3Given that my child has a high-grade glioma, time is a major concern — how long does the molecular profiling process typically take, and could participation in this trial delay starting any treatment?
4If the profiling shows my child has a specific mutation, like the H3 K27M mutation associated with diffuse midline glioma, does this trial then connect them to a specific targeted treatment protocol, and what would that next step actually look like?
5Are there situations where the molecular profiling might come back without a clearly actionable result, and if so, what treatment path would you recommend for my child outside of this trial?
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
Molecular profiling
Timeframe: 4 years
2
Feasibility of molecular profiling and enrollment to a TarGeT treatment protocol
. Tumor Sample Availability OR results from previous molecular profiling/targeted sequencing
. Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
. Enrollment timeline: Patients are eligible to enroll on the TarGeT-SCR anytime between diagnosis and the following specific timepoints post completion of RT (if relevant)
Exclusion criteria
Tumors that do not meet HGG and DIPG diagnoses specified above