Brain tumor DNA test could match kids to smarter treatments
NCT ID NCT05839379
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This study uses genetic testing of brain tumors from children, adolescents, and young adults (ages 1 to 39) with newly diagnosed high-grade glioma, including DIPG. The goal is to identify specific genetic changes in each tumor and then see if patients can join a treatment trial tailored to those changes. Up to 350 participants will have their tumors analyzed, and researchers will also study inherited cancer risks. This is a screening study, not a direct treatment trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors choose more effective, personalized treatments for young brain tumor patients based on their tumor's genetic makeup.
- What could go wrong
- This is an early-stage screening study, not a treatment trial. It may not lead to better outcomes for all participants, and some patients may not be eligible for a targeted therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Aug 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pediatric and young adult patients new diagnosed with High Grade Glioma including Diffuse Intrinsic Pontine Glioma (per 2021 WHO CNS tumor classification)
- Ages
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12 months to 39 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age: Patients must be ≥12 months and ≤39 years of age at the time of enrollment onto this screening protocol. 2. 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. 3. Disease Status: There are no disease status requirements for enrollment. * Measurable disease is not required. Patients without measurable disease are eligible. * Patients with metastatic/disseminated or multifocal disease or gliomatosis cerebri are eligible. * Patients with a primary spinal tumor are eligible. * Patients with secondary, radiation related HGG are eligible. 4. 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. * Participants screening for assignment to TarGeT-L may not have received radiation. Timing from surgery to start of RT: For patients who have started RT, radiation must have started \<42 days from definitive surgery or biopsy, however it is strongly recommended patients start RT within 31 days from definitive surgery (if patient had two surgeries, radiation must have started within 31 days from second surgery). 5. Tumor Sample Availability OR results from previous molecular profiling/targeted sequencing * If a patient screens through OPTION #1, tumor sample in addition to normal comparator tissue (peripheral blood, saliva, or buccal swab) must be submitted for comprehensive molecular screening at the time of screening enrollment. * If a patient screens through OPTIONS #2 or #3, results from previously performed molecular profiling must be submitted following enrollment. It is highly recommended that results be uploaded within 7 days of enrollment (if results are available at time of enrollment) or within 7 days of results becoming available (if pending at time of enrollment) to allow adequate time for central review. 6. 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. 7. 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) * Patients screening through OPTION #1 are eligible to enroll anytime between diagnosis and 10 days post RT (if completing RT). * Patients screening through OPTIONS #2 or #3 are eligible to enroll anytime between diagnosis and 21 days post RT (if completing RT). * Participants screening for TarGeT-L (lorlatinib) are eligible to enroll on TarGeT-SCR anytime between diagnosis and 31 days post definitive surgery (to allow time for molecular review). However, it is important to note the following: * For treatment protocols that include targeted therapy administered concurrently with RT, patients must start treatment within 10 calendar days of starting RT. * For treatment protocols that only include maintenance/adjuvant therapy (no systemic therapy given concurrently with radiation), patients must start treatment by 35 days post RT #SCREENING OPTIONS * OPTION1: Molecular screening through CONNECT TarGeT Clinical Testing Laboratories * OPTION2: Molecular screening through a national comprehensive tumor profiling program * OPTION3: Clinically validated targeted sequencing or focused profiling Exclusion Criteria: -Tumors that do not meet HGG and DIPG diagnoses specified above
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
22 sites in 7 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITINGChicago, Illinois, 60611, United States
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C.S. Mott Children's Hospital
RECRUITINGAnn Arbor, Michigan, 48109, United States
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Children's Hospital Colorado
NOT_YET_RECRUITINGAurora, Colorado, 80045, United States
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Children's Hospital of Philadelphia
NOT_YET_RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Children's National Medical Center
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Cincinnati Children's Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45229, United States
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Dana-Farber Cancer Institute
NOT_YET_RECRUITINGBoston, Massachusetts, 02215, United States
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Duke University Health System
RECRUITINGDurham, North Carolina, 27708, United States
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Great Ormond Street Hospital
NOT_YET_RECRUITINGLondon, WC1N 3JH, United Kingdom
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Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)
NOT_YET_RECRUITINGHeidelberg, Baden-Wurttemberg, 69120, Germany
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Montreal Children's Hospital
NOT_YET_RECRUITINGMontreal, Quebec, H4A3J1, Canada
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Nationwide Children's Hospital
RECRUITINGColumbus, Ohio, 43205, United States
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Perth Children's Hospital
RECRUITINGPerth, Western Australia, 6000, Australia
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Princess Máxima Center
NOT_YET_RECRUITINGUtrecht, 3720, Netherlands
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Queensland Children's Hospital
RECRUITINGSouth Brisbane, Queensland, 4101, Australia
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Royal Children's Hospital
RECRUITINGMelbourne, Victoria, 3052, Australia
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Seattle Children's Hospital
RECRUITINGSeattle, Washington, 98105, United States
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Starship Children's Hospital
NOT_YET_RECRUITINGAuckland, Grafton, 1023, New Zealand
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Sydney Children's Hospital
RECRUITINGRandwick, New South Wales, 2031, Australia
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Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
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The Hospital for Sick Children (SickKids)
NOT_YET_RECRUITINGToronto, Ontario, M5G1X8, Canada
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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