Observational Study of Responses to Treatments in Advanced Central Nervous System (CNS) Tumors

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07374692
Status
Recruiting
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Conditions

  • Brain Cancer
  • Gliomas
  • IDH-mutant Gliomas
  • IDH-wildtype Gliomas
  • Rare CNS Tumor
  • Recurrent CNS Tumors

Eligibility Criteria

Sex
ALL
Age
15 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Tumor sample collection — OTHER
    Fresh tumor samples will be collected for the study only if available following a planned biopsy or resection performed at NIH.

Study Details

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....

Key Dates

Start date
Feb 4, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2030
Completion
Dec 30, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: 1/SmartMatch testing
    Turnaround time for SmartMatch platform implementation and molecular profiling of recurrent CNS tumors

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

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
National Cancer Institute Referral Office
[email protected]
888-624-1937

Find similar trials in Bethesda, MD

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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