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

NCT ID: NCT05834426

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Plasma metabolomic profile 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sociedad de Lucha Contra el Cáncer del Ecuador

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katherine García Matamoros, MD

Role: PRINCIPAL_INVESTIGATOR

Sociedad de Lucha Contra el Cáncer del Ecuador

Fernanda Bertuccez Cordeiro, PhD

Role: PRINCIPAL_INVESTIGATOR

Escuela Superior Politécnica del Litoral

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto Oncológico Nacional Dr. Juan Tanca Marengo

Guayaquil, Guayas, Ecuador

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ecuador

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Katherine García Matamoros, MD

Role: CONTACT

5933718300 ext. 2385

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Katherine García Matamoros

Role: primary

5933718300 ext. 2385

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36733398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31097684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27085327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30814649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33982817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29396295 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36384092 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CISOLGYE20230021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.