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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 120
Healthy Volunteers: f
View:

• 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.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Christine T McGowan
christine.mcgowan@nih.gov
(240) 858-7330
Backup
Jing Wu, M.D.
jing.wu3@nih.gov
(240) 760-6036
Time Frame
Start Date: 2026-02-04
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 80
Treatments
Other: 1/SmartMatch testing
Turnaround time for SmartMatch platform implementation and molecular profiling of recurrent CNS tumors
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov