Characterization of Primary Central Nervous System Diffuse Large B Cell Lymphoma (PCNS-DLBCL) by Multiomic Approach

NCT07147751 | Not Yet Recruiting

• 1 other identifier: IELSG57
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

PCNS-DLBCL is a rare extranodal non-Hodgkin lymphoma that primarily affects the brain, spine, or vitreoretinal space. The prognosis for PCNS-DLBCL is significantly worse than that for its systemic counterpart. Understanding how and where this tumor initiates, and how it survives or depends on the microenvironment of the CNS is key to understanding the underlying biology and identifying reliable biomarkers for selecting personalized therapy or for biologically directed therapy that could improve the cure rate of CNS lymphomas.

Conditions

Primary Central Nervous System Diffuse Large B Cell Lymphoma (PCNS-DLBCL)

Outcome Measures

Primary Outcomes (5)

• Prevalence of non-GC phenotype

  12 months: from the end of samples collection to the end of study analysis

• Prevalence of mutations, copy number abnormalities, and structural variants

  12 months: from the end of samples collection to the end of study analysis

• Prevalence of PCNS-DLBCL molecular subtypes defined by genetic lesions

  12 months: from the end of samples collection to the end of study analysis

• Prevalence of PCNS-DLBCL molecular subtypes defined by gene expression signatures

  12 months: from the end of samples collection to the end of study analysis

• Prevalence of PCNS-DLBCL molecular subtypes defined by genetic methylation profile

  12 months: from the end of samples collection to the end of study analysis

Secondary Outcomes (3)

• Prevalence of molecular features of clinical, laboratory, and radiological features

  12 months: from the end of samples collection to the end of study analysis

• Prevalence of PCNS-DLBCL immunological signatures defined by gene expression profiling

  12 months: from the end of samples collection to the end of study analysis

• 3. Prevalence of PCNS-DLBCL MicroRNA signatures defined by miRNOMA evaluation

  12 months: from the end of samples collection to the end of study analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults patients with primary central nervous system diffuse large B cell lymphoma (PCNS-DLBCL)

You may qualify if:

• Be an adult immunocompetent patient who received a PCNS-DLBCL diagnosis according to the WHO-HAEM5 criteria between 2018 and 2024.
• Availability of formalin-fixed paraffin-embedded (FFPE) diagnostic tumor material.
• Availability of the baseline and follow-up annotations

You may not qualify if:

• Established immunodeficiency conditions.
• Secondary CNS localizations of DLBCL
• Transformed DLBCL

Sponsors & Collaborators

• International Extranodal Lymphoma Study Group (IELSG): lead

Study Sites (2)

Fondazione IRCCS Policlinico San Matteo Pavia

Pavia, 27100, Italy

Location

Oncology Institute of Southern Switzerland and Institute of Oncology Research

Bellinzona, 6500, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Already existing and coded tumor biological material will be retrospectively collected from institutional biobanks upon receipt of ethical approval

Study Officials

• Marco Paulli, MD

  Unit of Pathology, IRCCS Policlinico San Matteo Foundation and Department of Molecular Medicine, University of Pavia (IT)

  STUDY CHAIR

• Marco Lucioni, MD

  Unit of Pathology, IRCCS Policlinico San Matteo Foundation and Department of Molecular Medicine, University of Pavia (IT)

  STUDY CHAIR

Central Study Contacts

International Extranodal Lymphoma Study Group - IELSG

CONTACT

+41 58 666 7321; ielsg@ior.usi.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); CH (1)