Clinical trial · Observational
Observational Study of Responses to Treatments in Advanced Central Nervous System (CNS) Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Gliomas | Glioma | ALIAS | 0.90 |
| IDH-mutant Gliomas | — | UNRESOLVED | — |
| IDH-wildtype Gliomas | — | UNRESOLVED | — |
| Rare CNS Tumor | — | UNRESOLVED | — |
| Recurrent CNS Tumors | Central Nervous System Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SmartMatch testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 1/ IDH-wild-type
- description
- Participants with recurrent IDH-wild type high-grade glioma
- interventionNames
- Other: SmartMatch testing
- label
- 2/ IDH-mutant
- description
- Participants with recurrent IDH-mutant gliomas
- interventionNames
- Other: SmartMatch testing
- label
- 3/ Other
- description
- Other recurrent CNS tumors
- interventionNames
- Other: SmartMatch testing
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 120 Years
Show eligibility criteria text
* 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.
References
Publications (3)
- BACKGROUNDOstrom QT, Price M, Neff C, Cioffi G, Waite KA, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2015-2019. Neuro Oncol. 2022 Oct 5;24(Suppl 5):v1-v95. doi: 10.1093/neuonc/noac202. PMID 36196752
- BACKGROUNDAldape K, Brindle KM, Chesler L, Chopra R, Gajjar A, Gilbert MR, Gottardo N, Gutmann DH, Hargrave D, Holland EC, Jones DTW, Joyce JA, Kearns P, Kieran MW, Mellinghoff IK, Merchant M, Pfister SM, Pollard SM, Ramaswamy V, Rich JN, Robinson GW, Rowitch DH, Sampson JH, Taylor MD, Workman P, Gilbertson RJ. Challenges to curing primary brain tumours. Nat Rev Clin Oncol. 2019 Aug;16(8):509-520. doi: 10.1038/s41571-019-0177-5. PMID 30733593
- BACKGROUNDNishida-Aoki N, Bondesson AJ, Gujral TS. Measuring Real-time Drug Response in Organotypic Tumor Tissue Slices. J Vis Exp. 2020 May 2;(159). doi: 10.3791/61036. PMID 32420994