NCT04300101 Mixed Molecular Clinical Index (MMCI) in Diffuse Large B-cell Lymphoma (DLBCL)
| NCT ID | NCT04300101 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-05-14 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2020-05-14 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Gerardo Musuraca, MD
PRINCIPAL INVESTIGATOR
IRST IRCCS
Frequently Asked Questions
Who can join the NCT04300101 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04300101 currently recruiting?
Yes, NCT04300101 is actively recruiting participants. Contact the research team at oriana.nanni@irst.emr.it for enrollment information.
Where is the NCT04300101 trial being conducted?
This trial is being conducted at Meldola, Italy, Ravenna, Italy, Bologna, Italy, Rimini, Italy.
Who is sponsoring the NCT04300101 clinical trial?
NCT04300101 is sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. The principal investigator is Gerardo Musuraca, MD at IRST IRCCS. The trial plans to enroll 300 participants.