Clinical trial NCT05834426: Omic Technologies Applied to the Study of B-cell Lymphoma for the Discovery of Diagnostic and Prognosis Biomarkers
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphoma, B-Cell
Neoplasms
Cancer
High-grade B-cell Lymphoma
Diffuse Large B Cell Lymphoma
Non Hodgkin Lymphoma
Metabolomics
Keywords: Metabolomic Analysis
Lead sponsor: Sociedad de Lucha Contra el Cáncer del Ecuador
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma according to the 2022 WHO classification

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in plasma concentration as measured by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)
timeFrame: 12 months
Secondary outcomes:
measure: Progression-Free-Survival (PFS) related to the plasma metabolomic profile
timeFrame: 12 months
measure: Prognostic factors as measured by the National Comprehensive Cancer Network International Prognostic Index (NCCN-IPI)
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Instituto Oncológico Nacional Dr. Juan Tanca Marengo
state: Guayas
Study officials:
affiliation: Sociedad de Lucha Contra el Cáncer del Ecuador
name: Katherine García Matamoros, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Escuela Superior Politécnica del Litoral
name: Fernanda Bertuccez Cordeiro, PhD
role: PRINCIPAL_INVESTIGATOR
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