Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)

Study Overview
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Brief Summary
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The trial will enroll 194 previously untreated DLBCL patients over 20 months, with the objective to send to the local investigator an extensive molecular tumor characterization by D38 in at least 80% of enrolled patients. The feasibility and efficiency will be demonstrated by deploying and operating a nation-wide network of dedicated multidisciplinary platforms.

Official Title
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Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Procedure: Biological samples collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DLBCL patients that will be eligible in front-line treatment for a combination of anthracycline-based chemotherapy plus anti-CD20 monoclonal antibody,Rituximab: R-CHOP 14, R-CHOP 21, R mini-CHOP, R-ACVBP, R-COPADEM. Patients treated with R-CHOP associated with an experimental drug ((polatuzumab, tazemetostat, venetoclax, entospletinib, lenalidomide, ibrutinib, anti PD1/anti PDL1 ….) A short corticotherapy (prednisone, maximum 7 days) given during pre-phase therapy is allowed. Eligible histological subtypes: in particular DLBCL NOS, PMBL, high grade B-cell lymphoma (HGBCL) withMYC and BCL2 and/or BCL6 rearrangements, HGBCL NOSFL grade 3B and untreated transformed low grade NHL. ≥ 18 years old, IPI = 0-5 With available tumor Biopsy (FFPE) that can be sent to RT3 platform at the time of inclusion (or the say after inclusion at the latest). Patient that underwent needle core biopsy samples are not excluded if sufficient material is available for molecular and histopathological explorations Exclusion Criteria: No available FFPE biopsy material or insufficient quality/quantity tumor samples according to prerequisite No signed informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Biological samples collection|In addition to collection and characterization of tumor biopsy samples done for diagnosis (standard care), collection of blood samples at study entry for further biological analyses.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real time report of molecular characterization | To timely report the molecular characterization (pathogenic, diagnostic, prognostic, theranostic markers) of previously untreated DLBCL patients prior to day 38(i.e. 38 days after starting inductive chemotherapy regimen, in at least 80% of enrolled patients | 38 days (i.e. 38 days after starting inductive chemotherapy regimen | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLBCL, Real time molecular characterization