Evaluating blood samples in patients with high-grade brain tumors
Prospective Observational Study for the Implementation of Liquid Biopsy in the Follow-up of Patients With High-grade Gliomas and Meningiomas
This study is testing if changes in cell-free DNA in blood samples can help doctors understand how high-grade brain tumors are changing and how well treatments are working for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 5 sites (Milano, MI and 4 other locations) |
| Trial ID | NCT05630664 on ClinicalTrials.gov |
What this trial studies
This project aims to assess the role of circulating cell-free DNA in plasma as a biomarker for tumor evolution in patients diagnosed with high-grade gliomas and meningiomas. The study involves collecting plasma samples at four key time points: before surgery, one month post-surgery, one month after completing radiotherapy, and at the time of radiological progression. By analyzing changes in the concentration of cell-free DNA, the study seeks to predict progression-free survival, overall survival, and response to therapies in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a brain lesion suspected to be a high-grade glioma or meningioma, who are scheduled for biopsy or surgical resection.
Not a fit: Patients with non-neoplastic brain lesions or those who cannot undergo MRI due to contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to monitor tumor progression and treatment response in patients with high-grade brain tumors.
How similar studies have performed: While the use of liquid biopsies is gaining traction, this specific approach in high-grade gliomas and meningiomas is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milano, MI and 4 other locations
- IRCCS Ospedale San Raffaele — Milano, Mi, Italy (Recruiting)
- Istituto Clinico Humanitas IRCCS — Rozzano, Mi, Italy (Not_yet_recruiting)
- Istituto Oncologico Veneto — Padova, Pd, Italy (Not_yet_recruiting)
- Istituto Nazionale Tumori Regina Elena — Roma, Rm, Italy (Active_not_recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Rm, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Gaetano Finocchiaro, MD — Ospedale San Raffaele, Milano, Italy
- Study coordinator: Gaetano Finocchiaro, MD
- Email: finocchiaro.gaetano@hsr.it
- Phone: +390226435568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.