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

June 19, 2023 updated by: Sociedad de Lucha Contra el Cáncer del Ecuador

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

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

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)
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
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
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad de Lucha Contra el Cáncer del Ecuador

Investigators

  • Principal Investigator: Katherine García Matamoros, MD, Sociedad de Lucha Contra el Cáncer del Ecuador
  • Principal Investigator: Fernanda Bertuccez Cordeiro, PhD, Escuela Superior Politécnica del Litoral

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CISOLGYE20230021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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