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 Type
OBSERVATIONAL
Enrollment
90
IRCCS Ospedale San Raffaele
Milan, MI, Italy
RECRUITINGIstituto Clinico Humanitas IRCCS
Rozzano, MI, Italy
NOT_YET_RECRUITINGIstituto Oncologico Veneto
Padova, PD, Italy
NOT_YET_RECRUITINGIstituto Nazionale Tumori Regina Elena
Roma, RM, Italy
ACTIVE_NOT_RECRUITINGFondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy
NOT_YET_RECRUITINGcfDNA correlation with PFS
To evaluate whether circulating free DNA concentration in plasma at diagnosis correlates with progression-free survival.
Time frame: 1-3 days before surgery until disease progression (or at month 12 after surgery in the absence of disease progression)
cfDNA correlation with OS
To valuate whether the concentration of circulating free DNA in plasma at the time of diagnosis correlates with overall survival
Time frame: 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
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.
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)
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.
Time frame: 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).
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)
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