To hear about similar clinical trials, please enter your email below
Trial Title:
Liquid Biopsy in High-grade Gliomas and Meningiomas
NCT ID:
NCT05630664
Condition:
High Grade Glioma
High Grade Meningioma
Conditions: Official terms:
Glioma
Meningioma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
The study population will consist of adult patients with a newly diagnosed brain lesion
compatible with high-grade glioma or high-grade meningioma, for whom a brain biopsy or
exeresis has been indicated. Patients of both sexes, aged between 18 and 85 years-old,
with a Karnofsky Performance Status (KPS)≥ 60 will be enrolled.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gaetano Finocchiaro, MD
Phone:
+390226435258
Email:
finocchiaro.gaetano@hsr.it
Investigator:
Last name:
Giulia Berzero, MD
Email:
Sub-Investigator
Facility:
Name:
Istituto Clinico Humanitas IRCCS
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Matteo Simonelli, MD
Email:
matteo.simonelli@hunimed.eu
Facility:
Name:
Istituto Oncologico Veneto
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Giuseppe Lombardi, MD
Email:
giuseppe.lombardi@iov.veneto.it
Facility:
Name:
Istituto Nazionale Tumori Regina Elena
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Quintino Giorgio D' Alessandris, MD
Email:
quintinogiorgio.dalessandris@policlinicogemelli.it
Investigator:
Last name:
Luca Boldrini, MD
Email:
Sub-Investigator
Start date:
October 1, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Collaborator:
Agency:
Alleanza Contro il Cancro
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05630664
