RecruitingNot ApplicableNCT05036564

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

Sponsor

IRCCS San Raffaele

Enrollment

70 participants

Start Date

Oct 16, 2020

Study Type

INTERVENTIONAL

Conditions

Primary CNS Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining patients with primary central nervous system lymphoma (PCNSL) — a rare type of lymphoma that occurs in the brain or spinal fluid — to better understand how to diagnose and treat it, and to track how people respond to therapy. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with PCNSL confirmed by brain biopsy - You have no major contraindications to brain biopsy, spinal fluid sampling, or standard chemotherapy - You are willing and able to give informed consent **You may NOT be eligible if...** - Your lymphoma has spread both inside and outside the brain at the same time - You have a type of brain lymphoma other than the DLBCL subtype - You have a serious medical condition that would make participation unsafe - You are pregnant or breastfeeding - You had another cancer (other than cured skin or cervical cancers) in the past 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELumbar 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.

Locations(1)

IRCCS Ospedale San Raffaele

Milan, Italy/Lombardy, Italy

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NCT05036564

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