Diagnosis; Objective RespOnse; THErApy

Not Applicable

• Conditions: Primary CNS Lymphoma
• Interventions: Procedure: Lumbar puncture

• 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
• Status Verified: 2021-09
• Study First Posted: 2021-09-05
• Last Update Submitted: 2021-09-05
• Last Update Posted: 2021-09-13
• Primary Completion: 2023-07-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study population - PCNSL	Lumbar puncture	Patients (pts) with clinical and radiological suspicion of PCNSL or with confirmed diagnosis of PCNSL will be enrolled to the protocol. They will represent the "Study population"
Control	Lumbar puncture	1. Pts with suspicion of secondary CNS lymphoma, that includes subjects with DLBCL and involvement of the CNS at presentation in association with systemic disease, or subjects with systemic DLBCL and CNS relapse during or after primary therapy. 2. Pts with histological diagnosis of systemic DLBCL at high risk of CNS relapse according to Institutional guidelines and patients with histological diagnosis of systemic high grade B cell lymphoma, according to 2017 WHO classification; 3. pts affected by neurological disorders that are usually differential diagnosis of PCNSL (i.e. neurodegenerative and neuroinflammatory disorders, toxic or infective encephalitis, other primary CNS tumors).

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