Actively Recruiting

Age: 18Years +
All Genders
NCT04300101

Mixed Molecular Clinical Index (MMCI) in Diffuse Large B-cell Lymphoma (DLBCL)

Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2025-04-10

300

Participants Needed

4

Research Sites

415 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective and retrospective observational study. The primary objective is to identify new prognostic biomarkers for DLBCL patients in terms of progression-free survival (PFS) and able to add predictive capacity to recognized important clinical factors. The secondary objectives are: * to identify new biomarkers associated with overall survival (OS) and objective response rate (ORR) * to characterize tissue and circulating immune microenvironment of DLBCL patients by bulk and single cell transcriptomics; * to assess the correlation between the expression of immune checkpoint genes and mRNA signature; * to describe the mutational status of a panel of genes relevant to DLBCL pathogenesis;. * to assess the correlation between protein expression, mutational status and the messenger RNA (mRNA) signature. * to investigate the association between radiomic features obtained from PET images and patient and tumour characteristics and clinical outcomes (PFS, OS, ORR). For each enrolled patient, immunohistochemical determinations will be performed: Cell of origin (COO) (Germinal Cell -GC- or activated B-cell - ABC- type according with Hans algorithm ), evaluation of cluster of differentiation antigen 20 (CD20), cluster of differentiation antigen 5 (CD5), cluster of differentiation antigen 10 (CD10), Bcl6, Bcl2 (cut off\>50%), Multiple Myeloma 1 / Interferon Regulatory Factor 4 protein (MUM1/IRF4), c-myc (cut off\>40%) and Ki67, fluorescence in situ hybridization (FISH) for c-myc and if rearranged, for Bcl2 e Bcl6 ). Moreover, paraffin embedded (FFPE) tumor specimens will be collected for RNA extraction and mRNA expression mutational and proteomics analysis, centralized at IRST-IRCCS.

CONDITIONS

Official Title

Mixed Molecular Clinical Index (MMCI) in Diffuse Large B-cell Lymphoma (DLBCL)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • New diagnosis of High grade Diffuse Large B-cell Lymphoma undergoing first line standard treatment
  • Signed written informed consent
  • Availability of paraffin-embedded (FFPE) tumor sample
  • Diagnosis of High grade Diffuse Large B-cell Lymphoma from 2011 to 2017
  • Availability of FFPE sample and clinical data
Not Eligible

You will not qualify if you...

  • Participation in clinical trials

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Irst Irccs

Meldola, FC, Italy, 47014

Actively Recruiting

2

Ospedale S. Maria delle Croci RAVENNA

Ravenna, RA, Italy, 48121

Actively Recruiting

3

L'Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola-Malpighi

Bologna, Italy

Actively Recruiting

4

Ospedale Infermi

Rimini, Italy, 47924

Actively Recruiting

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Research Team

O

Oriana Nanni, Dr

CONTACT

B

Bernadette Vertogen, Dr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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