Recruiting

SmartMatch

Sponsor:

National Cancer Institute (NCI)

Code:

NCT07374692

Conditions

Recurrent CNS Tumors

Brain Cancer

Gliomas

IDH-wildtype Gliomas

IDH-mutant Gliomas

Eligibility Criteria

Sex: All

Age: 15 - 70+

Healthy Volunteers: Not accepted

Interventions

Tumor sample collection

Study Details

Brief summary:

Background:

Primary central nervous system (CNS) tumors grow in the brain and spinal cord. These tumors are rare, but they are difficult to treat and often fatal. SmartMatch is a new technology that tries to help find the best medicines for the particular tumor by testing how small pieces of surgically removed tumor tissue react to different drugs. The study team wants to see if SmartMatch can complete the analysis and generate a report within 21 days from the time of the surgery.

Objective:

To better understand CNS tumors so doctors can find better ways to treat them in the future.

Eligibility:

People aged 15 years and older with recurrent CNS tumors. Patient must already be scheduled for a surgery for the tumor at the NIH.

Design:

The study team will collect a small amount of tumor samples during the planned surgery. They may also use tumor samples from previous procedures. No new or additional procedures will be done for the purpose of this study.

The tumor samples will be sent to a lab for SmartMatch analysis. Once completed, the results will be shared with the patient and his/her local doctor. Together they can decide whether to incorporate the results into the treatment plan. It is important to know that the results may or may not be helpful.

There will only be one blood test for research. Blood and tissue samples collected may be used for additional analysis. Tumor tissue may be used to grow additional samples for further study. Participants will receive a pathology diagnosis and mutation profile generated by pathologists who specialize in CNS tumors.

The study team will seek updates on participant's health approximately every 6 months for 3 years. Tumor samples may also be collected from any additional surgery done at NIH during this time....

Conditions

Recurrent CNS Tumors

Brain Cancer

Gliomas

IDH-wildtype Gliomas

IDH-mutant Gliomas

Study ID

NCT07374692

Start date

Feb 4, 2026

Status verified date

Mar 25, 2026

Completion date

Dec 30, 2030

Anticipated

Primary completion date

Dec 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: 1/SmartMatch testing

Turnaround time for SmartMatch platform implementation and molecular profiling of recurrent CNS tumors

Interventions

Tumor sample collection

Fresh tumor samples will be collected for the study only if available following a planned biopsy or resection performed at NIH.

Primary outcome measure

  • To determine the proportion of participants with advanced CNS tumors for whom SmartMatch drug screen analysis results are generated within 21 days from the time of tumor tissue acquisition [ Time Frame: 21 days from the time of tumor tissue acquisition ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

National Cancer Institute Referral Office

888-624-1937ncimo_referrals@mail.nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

May 22, 2026

Last verified

Mar 25, 2026

Keywords

  • CNS Tumor
  • Brain Tumor
  • Rare Tumor
  • SmartMatch
  • Gliomas
  • Drug Screen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-05-22.