Omic Technologies Applied to the Study of B-cell Lymphoma for the Discovery of Diagnostic and Prognosis Biomarkers

Study Overview
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Brief Summary
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The goal of this observational study is to determine the plasma metabolomic profile in diffuse large B-cell lymphoma and high-grade B lymphomas patients before, during and after treatment by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)

Detailed Description
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The main question it aims to answer is the correlation between the plasma metabolomic profile of diffuse large B-cell lymphoma and high-grade B lymphomas patients before and after treatment determined by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS) and analysed with MetaboAnalyst web platform to identify specific over- or under-expressed markers.

Official Title
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Omic Technologies Applied to the Study of Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma for the Discovery of Diagnostic and Prognosis Biomarkers

Conditions
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Metabolomics, Lymphoma, B-Cell, Neoplasms, Cancer, High-grade B-cell Lymphoma, Diffuse Large B Cell Lymphoma, Non Hodgkin Lymphoma

Intervention / Treatment
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* Diagnostic Test: Plasma metabolomic profile by Ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older; Both sexes; Patients with confirmed histopathological diagnosis of Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma; Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2; Patient intending to receive full-dose treatment (Monoclonal antibodies plus anthracycline based combination chemotherapy); Staged with PET-CT or CT. Exclusion Criteria: Patients with comorbidities that may interfere with the interpretation of the results (CKD in dialysis phase, Autoimmune diseases, uncontrolled Diabetes Mellitus (DM), symptomatic Heart Failure (CHF), HIV positive, positive serology for hepatitis B and C); Patients requiring multiple blood transfusions (4 or more blood components for the same period or cause); Pregnant women; First-line treatment in another institution; Diffuse transformed Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

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 |
| --- |
|Diagnostic Test: Plasma metabolomic profile by Ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)|For metabolomic analysis, different portions of the blood (plasma and lymphocytes) will be subjected to metabolite extraction by the extraction method defined by Glasgow Polyomics. With protein precipitation, 200 microliters (uL) of the fluid with the metabolites is transferred to a new microtube and must be maintained at -80 °C until the time of metabolomic analysis.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma concentration as measured by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS) | For metabolomic analysis, different portions of the blood (plasma and lymphocytes) will be subjected to metabolite extraction by the extraction method defined by Glasgow Polyomics. With protein precipitation, 200 microliters (uL) of the fluid with the metabolites is transferred to a new microtube and must be maintained at -80 °C until the time of metabolomic analysis. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free-Survival (PFS) related to the plasma metabolomic profile | Progression-Free-Survival calculates the time from patient treatment to disease recurrence or death due to disease progression related to the metabolomic profile during the time of observation | 12 months | 
| Prognostic factors as measured by the National Comprehensive Cancer Network International Prognostic Index (NCCN-IPI) | The NCCN-IPI is a robust and useful tool to stratify prognostically relevant subgroups of Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma patients in the current era of rituximab-based therapy | 12 months | 
| Correlation between change in plasma metabolomic profile and treatment response as measured by Lugano criteria by PET-CT (positron emission tomography / computer tomography) or CT (computer tomography) scan | A correlation between change in plasma metabolomic profile and treatment response as measured by Lugano criteria by PET-CT or CT scan will be analysed using the Pearson's and Spearman's coefficients. The Lugano classification is used for assessment, staging and response of Hodgkin lymphoma and non-Hodgkin lymphoma. Criteria responses range from complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD), with progressive disease (PD) indicating worse response to treatment. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolomic Analysis