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

NCT04300101 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-04-10

No results posted yet for this study

Summary

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

Interventions

OTHER

Prospective cohort

Immunohistochemical determinations: Cell of Origin (COO) (according with Hans algorithm), evaluation of Cluster of Differentiation (CD) (CD20, CD5, CD10), Bcl6, Bcl2 (cut off\>50%), MUM1/IRF4, c-myc (cut off\>40%) and Ki67, FISH for c-myc and if rearranged for Bcl2 e Bcl6. mRNA expression by Nanostring Single cell analysis Immune checkpoint expression Proteomic analysis Metabolic analysis Radiomic analysis

OTHER

Retrospective cohort

Immunohistochemical determinations: Cell of Origin (COO) (according with Hans algorithm), evaluation of Cluster of Differentiation (CD) (CD20, CD5, CD10), Bcl6, Bcl2 (cut off\>50%), MUM1/IRF4, c-myc (cut off\>40%) and Ki67, FISH for c-myc and if rearranged for Bcl2 e Bcl6. mRNA expression by Nanostring Single cell analysis Immune checkpoint expression Proteomic analysis Metabolic analysis Radiomic analysis

Sponsors & Collaborators

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Gerardo Musuraca, MD · IRST IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-14
Primary Completion
2026-05-31
Completion
2028-05-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04300101 on ClinicalTrials.gov