Clinical trial NCT05630664: Liquid Biopsy in High-grade Gliomas and Meningiomas
Official title: Prospective Observational Study for the Implementation of Liquid Biopsy in the Follow-up of Patients With High-grade Gliomas and Meningiomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High Grade Glioma
High Grade Meningioma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Alleanza Contro il Cancro
First posted: 2022-11-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: cfDNA correlation with PFS
timeFrame: 1-3 days before surgery until disease progression (or at month 12 after surgery in the absence of disease progression)
Secondary outcomes:
measure: cfDNA correlation with OS
timeFrame: 1-3 days before surgery until patient death (or at month 12 if patient is alive)
measure: correlation between change in cfDNA concentration after surgery and PFS and OS
timeFrame: from day 30 (+/- 3 days) after surgery until disease progression, patient death (or at month 12 after surgery in the absence of disease progression)
measure: correlation between change in cfDNA concentration one month after radiotherapy completion and tumor volume changes, as well as clinical status changes
timeFrame: values assessed at month 3.5 after surgery (+/- one week) compared with values assessed 1-3 days before surgery
measure: cfDNA concentration changes at progression
timeFrame: 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)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas IRCCS
state: MI
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: PD
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
state: RM
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: RM
Study officials:
affiliation: Ospedale San Raffaele, Milano, Italy
name: Gaetano Finocchiaro, MD
role: PRINCIPAL_INVESTIGATOR
References: