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Trial Title:
Omic Technologies Applied to the Study of B-cell Lymphoma for the Discovery of Diagnostic and Prognosis Biomarkers
NCT ID:
NCT05834426
Condition:
Lymphoma, B-Cell
Neoplasms
Cancer
High-grade B-cell Lymphoma
Diffuse Large B Cell Lymphoma
Non Hodgkin Lymphoma
Metabolomics
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
Metabolomic Analysis
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Plasma metabolomic profile by Ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)
Description:
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.
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.
Criteria for eligibility:
Study pop:
Patients diagnosed with Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma
according to the 2022 WHO classification
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto Oncológico Nacional Dr. Juan Tanca Marengo
Address:
City:
Guayaquil
Zip:
090505
Country:
Ecuador
Contact:
Last name:
Katherine García Matamoros
Phone:
5933718300
Phone ext:
2385
Email:
comite_investigacion@solca.med.ec
Start date:
September 1, 2023
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Sociedad de Lucha Contra el Cáncer del Ecuador
Agency class:
Other
Source:
Sociedad de Lucha Contra el Cáncer del Ecuador
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05834426
