Liquid Biopsy in High-grade Gliomas and Meningiomas

Recruiting

• Conditions: High Grade Meningioma; High Grade Glioma

• Registration Number: NCT05630664
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study Start: 2022-10-01
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-24
• Last Update Submitted: 2022-11-29
• Study First Posted: 2022-11-30
• Last Update Posted: 2022-12-02
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cfDNA correlation with PFS	1-3 days before surgery until disease progression (or at month 12 after surgery in the absence of disease progression)	To evaluate whether circulating free DNA concentration in plasma at diagnosis correlates with progression-free survival.

Secondary Outcome Measures

Name	Time	Method
correlation between change in cfDNA concentration one month after radiotherapy completion and tumor volume changes, as well as clinical status changes	values assessed at month 3.5 after surgery (+/- one week) compared with values assessed 1-3 days before surgery	To evaluate, one month after the completion of radio (chemo) therapy (T2), the plasma concentration of circulating free DNA with respect to the pre-treatment values (T1), correlating with the volumetric and radiomic variations of the tumor in the magnetic resonance images (FLAIR sequence and T1 after injection of contrast medium), as well as with the changes in the patient's neurological status measured by the NANO score (Nayak et al., 2017) at the same timepoints.
cfDNA concentration changes at progression	values at the time of suspected radiological progression (or at month 12 in the absence of suspected radiological progression) compared with values assessed at month 3.5 after surgery (+/- one week)	To evaluate at the time of suspected radiological progression (T3) the plasma concentration of circulating free DNA and its variations compared to the values detected one month after the end of radio (chemo) therapy (T2).
cfDNA correlation with OS	1-3 days before surgery until patient death (or at month 12 if patient is alive)	To valuate whether the concentration of circulating free DNA in plasma at the time of diagnosis correlates with overall survival
correlation between change in cfDNA concentration after surgery and PFS and OS	from day 30 (+/- 3 days) after surgery until disease progression, patient death (or at month 12 after surgery in the absence of disease progression)	To evaluate whether a reduction in plasma concentration of circulating free DNA compared to preoperative values (T0) is seen one month after the surgical procedure (T1) and if this reduction is predictive of progression-free survival and overall survival.

Trial Locations

Locations (5)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, RM, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, MI, Italy

Istituto Clinico Humanitas IRCCS; 🇮🇹 Rozzano, MI, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, PD, Italy

Istituto Nazionale Tumori Regina Elena; 🇮🇹 Roma, RM, Italy