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NCT05934630 · ClinicalTrials.gov registry record
Testing Cerebrospinal Fluid for Cell-free Tumor DNA in Children, Adolescents, and Young Adults With Brain Tumors
A clinical trial, sponsored by Pediatric Brain Tumor Consortium.
- Terminated
- Registry status
- 57
- Enrollment target
NCT05934630: Clinical Trial study, sponsored by Pediatric Brain Tumor Consortium.
NCT05934630 is a clinical trial that was terminated before completion, run by Pediatric Brain Tumor Consortium. The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05934630 was terminated before completion, sponsored by Pediatric Brain Tumor Consortium.
- TERMINATED
- Registry status
- 57 participants
- Enrollment target
Study Summary
Recent advances in technology have allowed for the detection of cell-free DNA (cfDNA). cfDNA is tumor DNA that can be found in the fluid that surrounds the brain and spinal cord (called cerebrospinal fluid or CSF) and in the blood of patients with brain tumors. The detection of cfDNA in blood and CSF is known as a "liquid biopsy" and is non-invasive, meaning it does not require a surgery or biopsy of tumor tissue. Multiple studies in other cancer types have shown that cfDNA can be used for diagnosis, to monitor disease response to treatment, and to understand the genetic changes that occur in brain tumors over time. Study doctors hope that by studying these tests in pediatric brain tumor patients, they will be able to use liquid biopsy in place of tests that have more risks for patients, like surgery. There is no treatment provided on this study. Patients who have CSF samples taken as part of regular care will be asked to provide extra samples for this study. The study doctor will collect a minimum of one extra tube of CSF (about 1 teaspoon or 5 mL) for this study. If the patients doctor thinks it is safe, up to 2 tubes of CSF (about 4 teaspoons or up to 20 mL) may be collected. CSF will be collected through the indwelling catheter device or through a needle inserted into the lower part of the patient's spine (known as a spinal tap or lumbar puncture). A required blood sample (about ½ a teaspoon or 2 3 mL) will be collected once at the start of the study. This sample will be used to help determine changes found in the CSF. Blood will be collected from the patient's central line or arm as a part of regular care. An optional tumor tissue if obtained within 8 weeks of CSF collection will be collected if available. Similarities between changes in the DNA of the tissue that has caused the tumor to form and grow with the cfDNA from CSF will be compared. This will help understand if CSF can be used instead of tumor tissue for diagnosis. Up to 300 people will take part i
Primary Outcome
Within specific histologies with paired samples, estimate the concordance of mutation detected in the tumor tissue vs. cerebrospinal fluid cell free DNA (CSF cfDNA) across samples collected within 8 weeks of each other.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2023-07-12 |
| Est. Completion | 2026-04-17 |
Why NCT05934630 stopped before completion
NCT05934630 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 57 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05934630 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05934630 about?
NCT05934630 is a clinical study titled "Testing Cerebrospinal Fluid for Cell-free Tumor DNA in Children, Adolescents, and Young Adults With Brain Tumors". Recent advances in technology have allowed for the detection of cell-free DNA (cfDNA). cfDNA is tumor DNA that can be found in the fluid that surrounds the brain and spinal cord (called cerebrospinal fluid or CSF) and in the blood of patients with brain tumors. The detection of cfDNA in blood and CS...
What is the current status of trial NCT05934630?
This trial is currently terminated. The enrollment target is 57 participants. The study started on 2023-07-12. Estimated completion is 2026-04-17.
Who is sponsoring clinical trial NCT05934630?
This trial is sponsored by Pediatric Brain Tumor Consortium, which has 27 total clinical trials registered on ClinicalTrials.gov.
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