Prospective Observational Study for the Implementation of Liquid Biopsy in the Follow-up of Patients With High-grade Gliomas and Meningiomas

IRCCS San Raffaele5 sites in 1 country90 target enrollmentOctober 1, 2022

ConditionsHigh Grade Glioma High Grade Meningioma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: High Grade Glioma
Sponsor: IRCCS San Raffaele
Enrollment: 90
Locations: 5
Primary Endpoint: cfDNA correlation with PFS
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2022

End Date

September 30, 2025

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

IRCCS San Raffaele

Responsible Party

Principal Investigator

Gaetano Finocchiaro

IRCCS San Raffaele

Eligibility 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

Outcomes

Primary Outcomes

cfDNA correlation with PFS

Time Frame: 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 Outcomes

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)
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))
cfDNA correlation with OS(1-3 days before surgery until patient death (or at month 12 if patient is alive))
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))