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Recruiting
NCT05630664
Liquid Biopsy in High-grade Gliomas and Meningiomas
Conditions: High Grade Glioma, High Grade Meningioma
Sex: All
Ages: 18 Years – 85 Years
Enrollment: 90
Sponsor: IRCCS San Raffaele
Location: Italy
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.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 yearsFinding, 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 symptomsClinical indication to perform a biopsy or surgical resection of the lesionKarnofsky Performance Status (KPS) ≥ 60Signature of informed consentExclusion 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 HBVThere 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
Source: ClinicalTrials.gov (NCT05630664). StuddyBuddy aggregates publicly available trial information.