Diagnosis; Objective RespOnse; THErApy

Not Applicable

Recruiting

• Conditions: Primary CNS Lymphoma

• Registration Number: NCT05036564
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-16
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31
• Primary Completion: 2026-07-31
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Association between recurrent genetic alterations and PCNSL diagnosis or relapse	3 years and 6 months	Frequency of various genetic mutations among enrolled patients at diagnosis or relapse
Association between recurrent genetic alterations and residual enhanced and not-enhanced images at the MRI	3 years and 6 months	Frequency of various genetic mutations among enrolled patients during treatment

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy/Lombardy, Italy