Liquid Biopsy in High-grade Gliomas and Meningiomas

High Grade Glioma Clinical Trial

— SOPRANO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630664
• Other study ID #: ACCSOPRANO-22
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2022
• Source: IRCCS San Raffaele
• Contact: Gaetano Finocchiaro, MD
• Phone: +390226435568
• Email: finocchiaro.gaetano[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma
• High Grade Meningioma
• Meningioma

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milano	MI
Italy	Istituto Oncologico Veneto	Padova	PD
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	RM
Italy	Istituto Nazionale Tumori Regina Elena	Roma	RM
Italy	Istituto Clinico Humanitas IRCCS	Rozzano	MI

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	Alleanza Contro il Cancro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cfDNA correlation with PFS	To evaluate whether circulating free DNA concentration in plasma at diagnosis correlates with progression-free survival.	1-3 days before surgery until disease progression (or at month 12 after surgery in the absence of disease progression)
Secondary	cfDNA correlation with OS	To valuate whether the concentration of circulating free DNA in plasma at the time of diagnosis correlates with overall survival	1-3 days before surgery until patient death (or at month 12 if patient is alive)
Secondary	correlation between change in cfDNA concentration after surgery and PFS and OS	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.	from day 30 (+/- 3 days) after surgery until disease progression, patient death (or at month 12 after surgery in the absence of disease progression)
Secondary	correlation between change in cfDNA concentration one month after radiotherapy completion and tumor volume changes, as well as clinical status changes	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.	values assessed at month 3.5 after surgery (+/- one week) compared with values assessed 1-3 days before surgery
Secondary	cfDNA concentration changes at progression	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).	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)