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

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Phase changed: not applicable → not specified Final enrollment: 4 participants — 5% of the 80 planned · Trial completed · Primary completion date changed from estimate of Dec 30, 2030 to Sep 10, 2026 · 3 more Show 6 more changesShow less
    • Final enrollment: 4 participants — 5% of the 80 planned
    • Trial completed
    • Primary completion date changed from estimate of Dec 30, 2030 to Sep 10, 2026
    • Interventions modified
    • Trial arms changed: 1 → 3
    • Site details revised
  2. Minor Eligibility criteria expanded, about 8 words Study description expanded, about 10 words · Publications: details revised at 3 of 3 entries Show 2 more changesShow less
    • Study description expanded, about 10 words
    • Publications: details revised at 3 of 3 entries
  3. Minor 2 versions Re-verified since Mar 31, 2026, no change to tracked fieldsv4-v5
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 9, 2026 to Feb 4, 2026 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Feb 9, 2026 to Feb 4, 2026
    • Site details revised
  5. Minor Start date: Feb 3, 2026 to Feb 9, 2026v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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....
Trial Details
NCT Number NCT07374692
Lead Sponsor National Cancer Institute (NCI)
Conditions Recurrent CNS Tumors, Brain Cancer, Gliomas, IDH-wildtype Gliomas, IDH-mutant Gliomas, Rare CNS Tumor
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov