Clinical trial · Observational
Liquid Biopsy in High-grade Gliomas and Meningiomas
Prospective Observational Study for the Implementation of Liquid Biopsy in the Follow-up of Patients With High-grade Gliomas and Meningiomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The general objective of this project is to evaluate the value of cell-free DNA circulating in plasma as a marker of tumor evolution in patients with high-grade gliomas and meningiomas. To this end, we propose to longitudinally collect four samples of plasma at the following time points: * T0: before surgery; * T1: one month after surgery; * T2: one month after the end of radiotherapy; * T3 at the time of radiological progression. The goal is to evaluate whether changes in plasma concentration of circulating cell-free DNA can help predict progression-free survival, overall survival, and response to therapies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
| High Grade Meningioma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- cfDNA correlation with PFS
- timeFrame
- 1-3 days before surgery until disease progression (or at month 12 after surgery in the absence of disease progression)
- description
- To evaluate whether circulating free DNA concentration in plasma at diagnosis correlates with progression-free survival.
Secondary outcomes (4)
- measure
- cfDNA correlation with OS
- timeFrame
- 1-3 days before surgery until patient death (or at month 12 if patient is alive)
- description
- To valuate whether the concentration of circulating free DNA in plasma at the time of diagnosis correlates with overall survival
- measure
- correlation between change in cfDNA concentration after surgery and PFS and OS
- timeFrame
- from day 30 (+/- 3 days) after surgery until disease progression, patient death (or at month 12 after surgery in the absence of disease progression)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Finding, on an MRI scan of the brain with gadolinium, of a brain lesion compatible with a primary brain tumor, intra- or extra-axial, suspected for a high-grade glioma or a high-grade meningioma, manifested with new onset neurological symptoms * Clinical indication to perform a biopsy or surgical resection of the lesion * Karnofsky Performance Status (KPS) ≥ 60 * Signature of informed consent Exclusion Criteria: * Absolute contraindications to magnetic resonance imaging or to the administration of gadolinium (e.g. patients with pacemakers or other non-magneto-compatible devices) * Known positivity for HIV, HCV or HBV * There are clinical, biological or instrumental data suggesting that the brain lesion is non-neoplastic in nature (e.g., abscess, vascular malformation, inflammatory disease of the Central Nervous System) * Women who are pregnant or breastfeeding
References
Publications (0)
Data not yet available