Liquid Biopsy in High-grade Gliomas and Meningiomas

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05630664
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

IRCCS San Raffaele
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gaetano Finocchiaro, MD
Principal Investigator Affiliation Ospedale San Raffaele, Milano, Italy
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

High Grade Glioma, High Grade Meningioma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

IRCCS Ospedale San Raffaele, Milano, MI, Italy

Status

Recruiting

Address

IRCCS Ospedale San Raffaele

Milano, MI, 20132

Site Contact

Gaetano Finocchiaro, MD

[email protected]

+390226435258

Istituto Clinico Humanitas IRCCS, Rozzano, MI, Italy

Status

Not yet recruiting

Address

Istituto Clinico Humanitas IRCCS

Rozzano, MI, 20089

Site Contact

Matteo Simonelli, MD

[email protected]

+390226435568

Istituto Oncologico Veneto, Padova, PD, Italy

Status

Not yet recruiting

Address

Istituto Oncologico Veneto

Padova, PD, 35128

Site Contact

Giuseppe Lombardi, MD

[email protected]

+390226435568

Istituto Nazionale Tumori Regina Elena, Roma, RM, Italy

Status

Active, not recruiting

Address

Istituto Nazionale Tumori Regina Elena

Roma, RM, 00144

Roma, RM, Italy

Status

Not yet recruiting

Address

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168

Site Contact

Quintino Giorgio D' Alessandris, MD

[email protected]

+390226435568

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