Diagnosis; Objective RespOnse; THErApy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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 criteria

Qualifiers

Age ≥18 years

Newly diagnosed PCNSL with available clinical and radiological data, CSF and histopathological brain biopsy material fresh and/or formalin fixed and paraffin embedded;

No contraindications to stereotactic or open brain biopsy and lumbar puncture;

No formal contraindications to intravenous chemo-immunotherapy or whole-brain irradiation;

Disqualifiers

Patients with concomitant CNS and systemic involvement at presentation (potentially eligible as "control"; see below)

Patients with CNS lymphoma other than DLBCL subtype

Any other serious medical condition which could impair the ability of the patient to participate in the trial

Pregnant and lactating female patients. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation.

Trial design

Treatments tested in this trial

  • Lumbar puncture

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IRCCS San Raffaele

Lead sponsor

Teresa Calimeri

Collaborator

Sara Steffanoni

Collaborator