Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Italy/Lombardy, Italy, 20132
Actively Recruiting
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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