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Study identifier: NCT04300101 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Diffuse Large B Cell Lymphoma  ·  Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

PhaseN/A
Planned participants300
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Oriana Nanni, Dr  ·  +39 0543739100  ·  oriana.nanni@irst.emr.it

Bernadette Vertogen, Dr  ·  +39 0544285813  ·  cc.ubsc@irst.emr.it

Always discuss trial participation with your own doctor first.

Locations (4)

Irst IrccsMeldola, FC, ItalyRecruiting
Ospedale S. Maria delle Croci RAVENNARavenna, RA, ItalyRecruiting
L'Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola-MalpighiBologna, ItalyRecruiting
Ospedale InfermiRimini, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT04300101