Studies biomarkers that may predict how diffuse large B-cell lymphoma progresses
Looks at tumour samples and scans from adults with diffuse large B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: Mixed Molecular Clinical Index (MMCI) in Diffuse Large B-cell Lymphoma (DLBCL)
Key facts
- Where
- Bologna, Meldola, Ravenna, and Rimini, ItalySee the 4 sites
Where in Italy
- L'Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola-MalpighiBologna, ItalyTaking people
- Irst-IrccsMeldola, ItalyTaking people
- Ospedale S. Maria delle Croci RAVENNARavenna, ItalyTaking people
- Ospedale "Infermi"Rimini, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Trial code
- NCT04300101
- Record updated
- 10 April 2025
- Original description
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.Read full original descriptionShow less
Mixed Molecular Clinical Index (MMCI) in Diffuse Large B-cell Lymphoma (DLBCL)
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.
Inclusion: New diagnosis of High grade Diffuse large B cell Lymphoma undergoing first line standard treatment; Signed written informed consent; Availability of FFPE sample; Diagnosis of High grade Diffuse large B cell Lymphoma from 2011 to 2017; Availability of FFPE sample and clinical data.
Exclusion: Patients included in clinical trials.