Clinical trial · Observational
Mixed Molecular Clinical Index (MMCI) in Diffuse Large B-cell Lymphoma (DLBCL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prospective cohort | Other | — | UNRESOLVED |
| Retrospective cohort | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Prospective cohort
- description
- Prospective cohort: All patients with diagnosis of DLBCL afferring referred to IRST-IRCCS, Oncology-Hematology Units of AVR, S. Orsola Hospital (Bologna).
- interventionNames
- Other: Prospective cohort
- label
- Retrospective cohort
- description
- Retrospective cohort: Patients with diagnosis of DLBCL referred to IRST-IRCCS, from 2011 to 2017 for whom clinical data and FFPE samples are available.
- interventionNames
- Other: Retrospective cohort
Primary outcomes (1)
- measure
- identification of new prognostic biomarkers
- timeFrame
- 3 years
- description
- To identify new prognostic biomarkers for DLBCL patients that combined to clinical factors (IPI) are able to create a MMCI, predictive in terms of progression-free survival (PFS) of DLBCL patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for the prospective cohort: * New diagnosis of High grade Diffuse large B cell Lymphoma undergoing first line standard treatment; * Signed written informed consent; * Availability of FFPE sample. Inclusion Criteria for the retrospective cohort: * Diagnosis of High grade Diffuse large B cell Lymphoma from 2011 to 2017; * Availability of FFPE sample and clinical data. Exclusion Criteria: * Patients included in clinical trials.
References
Publications (0)
Data not yet available