UnknownNot Applicable

Liquid Biopsy in High-grade Gliomas and Meningiomas

Italy90 participantsStarted 2022-10-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Trial details

NCT IDNCT05630664

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-30

Contact for this trial

Gaetano Finocchiaro, MD

+390226435568 finocchiaro.gaetano@hsr.it

View on ClinicalTrials.gov More High Grade Glioma trials