NCT05036564

Diagnosis; Objective RespOnse; THErApy

Mutational Analysis in the Cerebrospinal Fluid to Improve Diagnostic Sensitivity, Response Definition and Precision Treatment in Primary Central Nervous System Lymphoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Thi is a prospective and low-intervention clinical trial. We propose to design a panel of "core" genetic alterations by sequencing Cerebral Spinal Fluid (CSF) DNA in patients with confirmed or suspicious Primary Central Neurvous System Lymphoma (PCNSL) with the aim to improve diagnostic sensitivity, response assessment and monitoring early CNS relapse in routine practice. Enrolled patients will receive conventional treatments according to well-established international guidelines, DNA assessments will not influence the treatment choices.

Conditions

• Primary CNS Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Lumbar puncture	A lumbar puncture (spinal tap) is performed in patient lower back, in the lumbar region. During a lumbar puncture, a needle is inserted between two lumbar bones (vertebrae) to remove a sample of cerebrospinal fluid (CSF). This is the fluid that surrounds brain and spinal cord to protect them from injury. This procedure is usually performed at the time of diagnosis for disease staging and/or repeated in the course of the disease history, only if positive or for clinical reasons (i.e. suspicious of relapse progression). In this study sequential CSF and peripheral blood samples of study population will be collected also at different time points, with the aim to improve diagnostics sensitivity, response assessment and monitoring early CNS relapse.

Timeline

• Start date: 2020-10-16
• Primary completion: 2026-07-31
• Completion: 2027-04-30
• First posted: 2021-09-05
• Last updated: 2025-05-31

Locations

1 site across 1 country: Italy