Liquid Biopsy in High-grade Gliomas and Meningiomas

NCT ID: NCT05630664

Last Updated: 2022-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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High Grade Glioma High Grade Meningioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alleanza Contro il Cancro

OTHER

Sponsor Role collaborator

IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Finocchiaro

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaetano Finocchiaro, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Raffaele, Milano, Italy

Locations

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IRCCS Ospedale San Raffaele

Milan, MI, Italy

Site Status RECRUITING

Istituto Clinico Humanitas IRCCS

Rozzano, MI, Italy

Site Status NOT_YET_RECRUITING

Istituto Oncologico Veneto

Padua, PD, Italy

Site Status NOT_YET_RECRUITING

Istituto Nazionale Tumori Regina Elena

Roma, RM, Italy

Site Status ACTIVE_NOT_RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Gaetano Finocchiaro, MD

Role: CONTACT

+390226435568

Giulia Berzero, MD, PhD

Role: CONTACT

+390226439575

Facility Contacts

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Gaetano Finocchiaro, MD

Role: primary

+390226435258

Matteo Simonelli, MD

Role: primary

Giuseppe Lombardi, MD

Role: primary

Quintino Giorgio D' Alessandris, MD

Role: primary

Other Identifiers

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ACCSOPRANO-22

Identifier Type: -

Identifier Source: org_study_id

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