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

NCT05834426 | Not Yet Recruiting

• 1 other identifier: CISOLGYE20230021
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

Metabolomic Analysis

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

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

  12 months

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

  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

  12 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sociedad de Lucha Contra el Cáncer del Ecuador: lead

Study Sites (1)

Instituto Oncológico Nacional Dr. Juan Tanca Marengo

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (7)

• Tian L, Li C, Sun J, Zhai Y, Wang J, Liu S, Jiang Y, Wu W, Xing D, Lv Y, Guo J, Xu H, Sun H, Li Y, Li L, Zhao Z. Efficacy of chimeric antigen receptor T cell therapy and autologous stem cell transplant in relapsed or refractory diffuse large B-cell lymphoma: A systematic review. Front Immunol. 2023 Jan 17;13:1041177. doi: 10.3389/fimmu.2022.1041177. eCollection 2022.

  PMID: 36733398 BACKGROUND

• Nowakowski GS, Feldman T, Rimsza LM, Westin JR, Witzig TE, Zinzani PL. Integrating precision medicine through evaluation of cell of origin in treatment planning for diffuse large B-cell lymphoma. Blood Cancer J. 2019 May 16;9(6):48. doi: 10.1038/s41408-019-0208-6.

  PMID: 31097684 BACKGROUND

• Carneiro BA, Costa R, Taxter T, Chandra S, Chae YK, Cristofanilli M, Giles FJ. Is Personalized Medicine Here? Oncology (Williston Park). 2016 Apr;30(4):293-303, 307.

  PMID: 27085327 BACKGROUND

• Rinschen MM, Ivanisevic J, Giera M, Siuzdak G. Identification of bioactive metabolites using activity metabolomics. Nat Rev Mol Cell Biol. 2019 Jun;20(6):353-367. doi: 10.1038/s41580-019-0108-4.

  PMID: 30814649 BACKGROUND

• Schmidt DR, Patel R, Kirsch DG, Lewis CA, Vander Heiden MG, Locasale JW. Metabolomics in cancer research and emerging applications in clinical oncology. CA Cancer J Clin. 2021 Jul;71(4):333-358. doi: 10.3322/caac.21670. Epub 2021 May 13.

  PMID: 33982817 BACKGROUND

• Pera B, Krumsiek J, Assouline SE, Marullo R, Patel J, Phillip JM, Roman L, Mann KK, Cerchietti L. Metabolomic Profiling Reveals Cellular Reprogramming of B-Cell Lymphoma by a Lysine Deacetylase Inhibitor through the Choline Pathway. EBioMedicine. 2018 Feb;28:80-89. doi: 10.1016/j.ebiom.2018.01.014. Epub 2018 Jan 31.

  PMID: 29396295 BACKGROUND

• Fahrmann JF, Saini NY, Chia-Chi C, Irajizad E, Strati P, Nair R, Fayad LE, Ahmed S, Lee HJ, Iyer S, Steiner R, Vykoukal J, Wu R, Dennison JB, Nastoupil L, Jain P, Wang M, Green M, Westin J, Blumenberg V, Davila M, Champlin R, Shpall EJ, Kebriaei P, Flowers CR, Jain M, Jenq R, Stein-Thoeringer CK, Subklewe M, Neelapu SS, Hanash S. A polyamine-centric, blood-based metabolite panel predictive of poor response to CAR-T cell therapy in large B cell lymphoma. Cell Rep Med. 2022 Nov 15;3(11):100720. doi: 10.1016/j.xcrm.2022.100720.

  PMID: 36384092 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples from patients with Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma at diagnosis, during and after treatment

MeSH Terms

Conditions

Lymphoma, B-Cell; Neoplasms; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Katherine García Matamoros, MD

  Sociedad de Lucha Contra el Cáncer del Ecuador

  PRINCIPAL INVESTIGATOR

• Fernanda Bertuccez Cordeiro, PhD

  Escuela Superior Politécnica del Litoral

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine García Matamoros, MD

CONTACT

5933718300; comite_investigacion@solca.med.ec

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 28, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)