Actively Recruiting
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
Eligibility Criteria
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
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
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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