NCT04300101

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
May 2020May 2028

First Submitted

Initial submission to the registry

March 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 14, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Expected
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

6 years

First QC Date

March 5, 2020

Last Update Submit

April 7, 2025

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse Large B cell lymphoma;cell of origingene expressionimmunohistochemistry

Outcome Measures

Primary Outcomes (1)

  • identification of new prognostic biomarkers

    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.

    3 years

Secondary Outcomes (7)

  • identification of molecular and clinical parameters

    3 years

  • characterization of tissue and circulating immune microenvironment

    3 years

  • immune checkpoint genes analysis

    3 years

  • mutational status

    3 years

  • Correlation of protein expression, mutational status and the mRNA signatures

    3 years

  • +2 more secondary outcomes

Study Arms (2)

Prospective cohort

Prospective cohort: All patients with diagnosis of DLBCL afferring referred to IRST-IRCCS, Oncology-Hematology Units of AVR, S. Orsola Hospital (Bologna).

Other: Prospective cohort

Retrospective cohort

Retrospective cohort: Patients with diagnosis of DLBCL referred to IRST-IRCCS, from 2011 to 2017 for whom clinical data and FFPE samples are available.

Other: Retrospective cohort

Interventions

Prospective cohortOTHER

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

Prospective cohort
Retrospective cohortOTHER

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

Retrospective cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective cohort: All patients with diagnosis of DLBCL afferring referred to IRST-IRCCS, Oncology-Hematology Units of AVR, S. Orsola Hospital (Bologna). Retrospective cohort: Patients with diagnosis of DLBCL referred to IRST-IRCCS, from 2011 to 2017 for whom clinical data and FFPE samples are available.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients included in clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Irst Irccs

Meldola, FC, 47014, Italy

RECRUITING

Ospedale S. Maria delle Croci RAVENNA

Ravenna, RA, 48121, Italy

RECRUITING

L'Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola-Malpighi

Bologna, Italy

RECRUITING

Ospedale Infermi

Rimini, 47924, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Formalin fixed Paraffin embedded (FFPE) tumor specimens and peripheral blood samples.

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Gerardo Musuraca, MD

    IRST IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oriana Nanni, Dr

CONTACT

+39 0543739100oriana.nanni@irst.emr.it

Bernadette Vertogen, Dr

CONTACT

+39 0544285813cc.ubsc@irst.emr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 9, 2020

Study Start

May 14, 2020

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2028

Last Updated

April 10, 2025

Record last verified: 2025-04

Locations

IT(4)