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| Name | Class |
|---|---|
| Alleanza Contro il Cancro | OTHER |
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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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| cfDNA correlation with OS | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaetano Finocchiaro, MD | Contact | +390226435568 | finocchiaro.gaetano@hsr.it | |
| Giulia Berzero, MD, PhD | Contact | +390226439575 | berzero.giulia@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Gaetano Finocchiaro, MD | Ospedale San Raffaele, Milano, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | MI | 20132 | Italy |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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plasma
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 | 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 | 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) |
| Istituto Clinico Humanitas IRCCS | Not yet recruiting | Rozzano | MI | 20089 | Italy |
|
| Istituto Oncologico Veneto | Not yet recruiting | Padova | PD | 35128 | Italy |
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| Istituto Nazionale Tumori Regina Elena | Active, not recruiting | Roma | RM | 00144 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Not yet recruiting | Roma | RM | 00168 | Italy |
|
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |