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NCT Number: NCT05834426

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

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)

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Key information

Conditions

Lymphoma, B-Cell Cancer Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases High-grade B-cell Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Metabolomics Neoplasms Neoplasms by Histologic Type Non Hodgkin Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Oncológico Nacional Dr. Juan Tanca Marengo

Guayaquil, Guayas, 090505, Ecuador

Location contact

Katherine García Matamoros

CONTACT

[email protected]

5933718300 ext. 2385

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma metabolomic profile by Ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)

Diagnostic Test

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Progression-Free-Survival (PFS) related to the plasma metabolomic profile

    Time frame: 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

  2. Prognostic factors as measured by the National Comprehensive Cancer Network International Prognostic Index (NCCN-IPI)

    Time frame: 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

  3. 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine García Matamoros, MD

CONTACT

[email protected]

5933718300 ext. 2385

Sponsors and collaborators

Lead sponsor

Sociedad de Lucha Contra el Cáncer del Ecuador

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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