SmartMatch testing of surgically removed tumor tissue to guide treatment for recurrent brain tumors
Observational Study of Responses to Treatments in Advanced Central Nervous System (CNS) Tumors
NA · National Institutes of Health Clinical Center (CC) · NCT07374692
This project will test whether SmartMatch can analyze tumor tissue from people aged 15 and older with recurrent brain tumors and return drug-response results within 21 days of surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 15 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Drugs / interventions | radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT07374692 on ClinicalTrials.gov |
What this trial studies
The team collects small pieces of tumor tissue during a planned biopsy or resection (or uses available prior samples) and runs real-time tissue-based drug screening using the SmartMatch platform. SmartMatch combines lab drug-response data with machine learning to generate a report suggesting which approved or repurposed drugs the tumor appears sensitive to. No extra procedures are required beyond the scheduled surgery, and the program aims to deliver results within 21 days of the operation. Data from tested samples will also be used to improve the underlying predictive models for future patients.
Who should consider this trial
Good fit: People aged 15 years or older with recurrent CNS tumors (including IDH-wildtype and IDH-mutant gliomas) who are already scheduled for biopsy or resection at the NIH Clinical Center.
Not a fit: Patients who are not having surgery at NIH, who cannot provide sufficient tumor tissue, or whose tumor shows no actionable drug sensitivities are unlikely to receive direct treatment benefit from this protocol.
Why it matters
Potential benefit: If successful, SmartMatch could identify drugs more likely to work for an individual's tumor and speed personalized treatment decisions.
How similar studies have performed: Ex vivo drug-sensitivity testing and AI-driven matching have shown promising early results in other cancers, but these approaches remain experimental for CNS tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA * Participants must have advanced CNS tumors confirmed by a documented pathology report, including: * recurrent isocitrate dehydrogenase (IDH)-wild-type high-grade glioma * recurrent IDH-mutant gliomas * other recurrent CNS tumors * Participants must have been scheduled for a brain tumor biopsy or resection. Note: Scheduled brain tumor biopsy or resection must be at least 6 months after any previous radiation therapy, if applicable. All procedures are planned to take place at NIH. * Age \>= 15 years. * Ability of participant, parent/guardian, or Legally Authorized Representative (LAR) to understand and sign a written informed consent document. EXCLUSION CRITERIA None.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Jing Wu, M.D. — National Cancer Institute (NCI)
- Study coordinator: Christine T McGowan
- Email: christine.mcgowan@nih.gov
- Phone: (240) 858-7330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Recurrent CNS Tumors, Brain Cancer, Gliomas, IDH-wildtype Gliomas, IDH-mutant Gliomas, Rare CNS Tumor, CNS Tumor, Brain Tumor