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Lymphoma, B-CellNCT05834426

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

An observational study of Lymphoma, B-Cell and Neoplasms, run by Sociedad de Lucha Contra el Cáncer del Ecuador at 1 site in Ecuador.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, B-Cell, Neoplasms, Cancer
What is being tested?
Plasma metabolomic profile by Ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)
How many people
50 participants
Where
1 siteEcuador
Study dates
1 Sep 2023to 31 Aug 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma according to the 2022 WHO classification

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Katherine García Matamoros, MD contact

5933718300 ext. 2385

comite_investigacion@solca.med.ec

Ecuador1 site

  • Instituto Oncológico Nacional Dr. Juan Tanca Marengo

    Guayaquil, Guayas, 090505

    Katherine García Matamoros, 5933718300 ext. 2385, comite_investigacion@solca.med.ec

Other trials in Ecuador

About this study

Official 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

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)

Read the 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.

Being tested
Plasma metabolomic profile by Ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)
Keywords
Metabolomic Analysis
Medical subject headings
Lymphoma, B-Cell, Neoplasms, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (3)

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

    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

    Measured: 12 months

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

    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

    Measured: 12 months

  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

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2023
  2. Study start1 Sep 2023 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05834426
Sponsor's protocol ID
CISOLGYE20230021
Status last verified
Jun 2023
First submitted
3 Apr 2023
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36733398

  • 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.

    PubMed 31097684

  • 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.

    PubMed 27085327

  • 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.

    PubMed 30814649

  • 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.

    PubMed 33982817

  • 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.

    PubMed 29396295

  • 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.

    PubMed 36384092

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, B-Cell and Neoplasms, run by Sociedad de Lucha Contra el Cáncer del Ecuador at 1 site in Ecuador.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Katherine García Matamoros, MD (5933718300 ext. 2385, comite_investigacion@solca.med.ec), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05834426, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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