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

Not yet recruiting

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

• Registration Number: NCT05834426
• Lead Sponsor: Sociedad de Lucha Contra el Cáncer del Ecuador

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-04-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Study Start: 2023-09-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in plasma concentration as measured by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Progression-Free-Survival (PFS) related to the plasma metabolomic profile	12 months	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
Prognostic factors as measured by the National Comprehensive Cancer Network International Prognostic Index (NCCN-IPI)	12 months	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
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	12 months	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.

Trial Locations

Locations (1)

Instituto Oncológico Nacional Dr. Juan Tanca Marengo; 🇪🇨 Guayaquil, Guayas, Ecuador