Liquid Biopsy in High-grade Gliomas and Meningiomas (SOPRANO)

November 29, 2022 updated by: Gaetano Finocchiaro, IRCCS San Raffaele

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
        • Sub-Investigator:
          • Giulia Berzero, MD
      • Rozzano, MI, Italy, 20089
    • PD
    • RM
      • Roma, RM, Italy, 00144
        • Active, not recruiting
        • Istituto Nazionale Tumori Regina Elena
      • Roma, RM, Italy, 00168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cfDNA correlation with PFS
Time Frame: 1-3 days before surgery until disease progression (or at month 12 after surgery in the absence of disease progression)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
cfDNA correlation with OS
Time Frame: 1-3 days before surgery until patient death (or at month 12 if patient is alive)
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)
correlation between change in cfDNA concentration after surgery and PFS and OS
Time Frame: from day 30 (+/- 3 days) after surgery until disease progression, patient death (or at month 12 after surgery in the absence of disease progression)
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)
correlation between change in cfDNA concentration one month after radiotherapy completion and tumor volume changes, as well as clinical status changes
Time Frame: values assessed at month 3.5 after surgery (+/- one week) compared with values assessed 1-3 days before surgery
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
cfDNA concentration changes at progression
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

Alleanza Contro il Cancro

Investigators

  • Principal Investigator: Gaetano Finocchiaro, MD, Ospedale San Raffaele, Milano, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

September 30, 2025

Study Completion (Anticipated)

September 30, 2025

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

November 24, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACCSOPRANO-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on High Grade Glioma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe