Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05036564

Diagnosis; Objective RespOnse; THErApy

Led by IRCCS San Raffaele · Updated on 2025-05-31

70

Participants Needed

1

Research Sites

341 weeks

Total Duration

On this page

Sponsors

I

IRCCS San Raffaele

Lead Sponsor

T

Teresa Calimeri

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Diagnosis; Objective RespOnse; THErApy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Newly diagnosed PCNSL with available clinical, radiological, cerebrospinal fluid (CSF), and brain biopsy material
  • No contraindications to stereotactic or open brain biopsy and lumbar puncture
  • No contraindications to intravenous chemo-immunotherapy or whole-brain irradiation
  • Provided written informed consent before any study procedures, understanding the right to withdraw at any time without prejudice
Not Eligible

You will not qualify if you...

  • Patients with both CNS and systemic lymphoma involvement at diagnosis
  • CNS lymphoma other than diffuse large B-cell lymphoma (DLBCL) subtype
  • Any serious medical condition that could impair participation in the trial
  • Pregnant or lactating females; sexually active patients of childbearing potential must use effective contraception
  • Previous or concurrent cancers within 3 years before PCNSL diagnosis, except surgically cured in situ carcinomas and basal cell skin carcinoma
  • Psychological, familial, sociological, or geographical conditions that could hinder study compliance and follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Ospedale San Raffaele

Milan, Italy/Lombardy, Italy, 20132

Actively Recruiting

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Research Team

A

Andrés J.M. Ferreri, MD

CONTACT

T

Teresa Calimeri, MD/PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Diagnosis; Objective RespOnse; THErApy | DecenTrialz