Liquid Biopsy in High-grade Gliomas and Meningiomas

NCT05630664 | Unknown

• 1 other identifier: ACCSOPRANO-22
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 5

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.

Conditions

High Grade Glioma; High Grade Meningioma

Outcome Measures

Primary Outcomes (1)

• cfDNA correlation with PFS

  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 Outcomes (4)

• cfDNA correlation with OS

  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

  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

  values assessed at month 3.5 after surgery (+/- one week) compared with values assessed 1-3 days before surgery

• cfDNA concentration changes at progression

  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)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Alleanza Contro il Cancro: collaborator

Study Sites (5)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

Istituto Clinico Humanitas IRCCS

Rozzano, MI, 20089, Italy

NOT YET RECRUITING

Istituto Oncologico Veneto

Padua, PD, 35128, Italy

NOT YET RECRUITING

Istituto Nazionale Tumori Regina Elena

Roma, RM, 00144, Italy

ACTIVE NOT RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Gaetano Finocchiaro, MD

  Ospedale San Raffaele, Milano, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano Finocchiaro, MD

CONTACT

+390226435568; finocchiaro.gaetano@hsr.it

Giulia Berzero, MD, PhD

CONTACT

+390226439575; berzero.giulia@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: November 30, 2022
• Study Start: October 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 2, 2022

Record last verified: 2022-11

Locations

IT (5)