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B-cell NeoplasmNCT06847529

Systemic Inflammatory Markers in B-cell Neoplasm

An observational study of B-cell Neoplasm, run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study was to evaluate the role of systemic inflammatory markers in predicting outcome for patients with B cell neoplasm Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Neoplasm
How many people
70 participants
Where
1 siteEgypt
Study dates
22 Mar 2025to 30 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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: Based on determining the main outcome variable, the estimated minimum required sample size is 74. The sample size was calculated using G*power software 3.1.9.4 , based on the following assumptions: Main outcome variable is the evaluation of role of systemic inflammatory markers in predicting outcome for patients with B cell neoplasm. Based on expert opinion we hypothesized to find medium effect size 0.3

Who may be able to join

  • Individuals newly diagnosed with B-cell neoplasms, including:
  • Burkitt's lymphoma (BL)
  • Chronic lymphocytic leukemia (CLL)
  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma (FL)
  • Hairy cell leukemia (HCL)
Show all 15Show fewer
  • Splenic B-cell lymphoma/leukemia with prominent nucleoli (SBLPN)
  • High-grade B-cell lymphoma (HGBL)
  • Lymphoplasmacytic lymphoma (LPL)/Waldenström macroglobulinemia
  • Mantle cell lymphoma (MCL)
  • Splenic marginal zone lymphoma (MZL)
  • Monoclonal B-cell lymphocytosis (MBL)
  • Multiple myeloma (plasma cell myeloma)
  • Monoclonal gammopathy of undetermined significance (MGUS)
  • Age 18 years or older.

Who cannot join

  • Individuals previously diagnosed with B-cell neoplasms.
  • Individuals younger than 18 years.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marlien Wiliam Fayez, Resident doctor contact

01156900472

Marlienwilliam1@gmail.com

Mai Mostafa Mohamed, Doctor contact

01223971678

Mai_heamatology@aun.edu.eg

Egypt1 site

  • Assiut University

    Asyut

Other trials in Egypt

About this study

Official title: Systemic Inflammatory Markers As a Prognostic Index for B-cell Neoplasm , Single Center Experience .

This study was to evaluate the role of systemic inflammatory markers in predicting outcome for patients with B cell neoplasm

Read the detailed description

In malignant tumors, Inflammation plays a crucial role in the development, invasion, and metastasis of malignant tumors. Cancer is often described as a wound that does not heal, highlighting the significance of inflammation in cancer progression. Many tumors are heavily infiltrated by immune cells, including macrophages, neutrophils, and lymphocytes. Therefore, markers related to inflammation and the host immune response are pertinent as biological indicators of B-cell neoplasm progression. Inflammation contributes significantly to the initiation and advancement of B-cell neoplasms by providing nutrients to tumor cells, promoting cell growth, and disrupting immune homeostasis. Various composite indices based on circulating inflammatory cells have been developed as straightforward measures to assess systemic inflammation. Elevated serum inflammatory markers reflect the body's response to malignant tumors. Pro-inflammatory cytokines and inflammatory cells within the tumor microenvironment have been shown to promote tumor growth, induce DNA damage, facilitate angiogenesis, suppress the immune system, and correlate with poor patient survival outcomes. Targeting cytokine receptors or other components in inflammatory pathways involved in metastasis may offer therapeutic potential for malignant tumors. Given the pivotal role of inflammation in cancer biology, identifying novel immune markers is essential for predicting the prognosis of patients with Diffuse Large B-Cell Lymphoma (DLBCL). patients

Conditions
B-cell Neoplasm
Keywords
Systemic inflammatory markers as a prognostic index
Medical subject headings
Lymphoma, B-Cell

What is being measured

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

  1. Determination of Optimal Cut-off Values for Systemic Inflammatory Indices in B-cell Neoplasms Using Laboratory Blood Tests

    This outcome measure aims to establish the optimal cut-off values for systemic inflammatory indices-including Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Lymphocyte-to-Monocyte Ratio (LMR)-using routine laboratory blood tests. The blood tests will include serum lactate dehydrogenase (LDH), globulin, albumin, C-reactive protein (CRP), platelet count, neutrophil count, lymphocyte count, and monocyte count. Receiver Operating Characteristic (ROC) curve analysis will be employed to determine the optimal cut-off values for each inflammatory marker.

    Measured: Baseline

Secondary outcomes (1)

  1. Prognostic Value of Baseline Systemic Inflammatory Markers on Overall Survival in B-cell Neoplasm Patients

    This outcome measure evaluates the association between baseline systemic inflammatory markers and overall survival in patients with B-cell neoplasms. The markers to be assessed include serum levels of LDH, globulin, albumin, CRP, and blood cell counts (neutrophils, lymphocytes, monocytes). Additionally, calculated indices such as NLR, PLR, LMR, CRP-to-Albumin Ratio (CAR), Albumin-to-Globulin Ratio (AGR), Systemic Immune-Inflammation Index (SII), and Systemic Inflammation Response Index (SIRI) will be determined. Patient follow-up will be conducted for 6 to 8 months or until the completion of the chemotherapeutic regimen or death.

    Measured: From baseline up to 8 months

Timeline

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

  1. First posted26 Feb 2025
  2. Study start22 Mar 2025 (estimated)
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion30 Dec 2025 (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
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06847529
Sponsor's protocol ID
markers In B-cell tumors
Status last verified
Mar 2025
First submitted
21 Feb 2025
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Elinav E, Nowarski R, Thaiss CA, Hu B, Jin C, Flavell RA. Inflammation-induced cancer: crosstalk between tumours, immune cells and microorganisms. Nat Rev Cancer. 2013 Nov;13(11):759-71. doi: 10.1038/nrc3611.

    PubMed 24154716

  • Liu FT, Jia L, Wang P, Farren T, Li H, Hao X, Agrawal SG. CD126 and Targeted Therapy with Tocilizumab in Chronic Lymphocytic Leukemia. Clin Cancer Res. 2016 May 15;22(10):2462-9. doi: 10.1158/1078-0432.CCR-15-1139. Epub 2015 Dec 28.

    PubMed 26712690

  • Drutskaya MS, Nosenko MA, Atretkhany KS, Efimov GA, Nedospasov SA. [Interleukin-6 From molecular mechanisms of signal transduction to physiological properties and therapeutic targeting]. Mol Biol (Mosk). 2015 Nov-Dec;49(6):937-43. doi: 10.7868/S0026898415060063. Russian.

    PubMed 26710772

  • Goumas FA, Holmer R, Egberts JH, Gontarewicz A, Heneweer C, Geisen U, Hauser C, Mende MM, Legler K, Rocken C, Becker T, Waetzig GH, Rose-John S, Kalthoff H. Inhibition of IL-6 signaling significantly reduces primary tumor growth and recurrencies in orthotopic xenograft models of pancreatic cancer. Int J Cancer. 2015 Sep 1;137(5):1035-46. doi: 10.1002/ijc.29445. Epub 2015 Jan 29.

    PubMed 25604508

  • Kurzrock R, Voorhees PM, Casper C, Furman RR, Fayad L, Lonial S, Borghaei H, Jagannath S, Sokol L, Usmani SZ, van de Velde H, Qin X, Puchalski TA, Hall B, Reddy M, Qi M, van Rhee F. A phase I, open-label study of siltuximab, an anti-IL-6 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma, multiple myeloma, or Castleman disease. Clin Cancer Res. 2013 Jul 1;19(13):3659-70. doi: 10.1158/1078-0432.CCR-12-3349. Epub 2013 May 9.

    PubMed 23659971

  • Beguelin W, Sawh S, Chambwe N, Chan FC, Jiang Y, Choo JW, Scott DW, Chalmers A, Geng H, Tsikitas L, Tam W, Bhagat G, Gascoyne RD, Shaknovich R. IL10 receptor is a novel therapeutic target in DLBCLs. Leukemia. 2015 Aug;29(8):1684-94. doi: 10.1038/leu.2015.57. Epub 2015 Mar 3.

    PubMed 25733167

  • Marri PR, Hodge LS, Maurer MJ, Ziesmer SC, Slager SL, Habermann TM, Link BK, Cerhan JR, Novak AJ, Ansell SM. Prognostic significance of pretreatment serum cytokines in classical Hodgkin lymphoma. Clin Cancer Res. 2013 Dec 15;19(24):6812-9. doi: 10.1158/1078-0432.CCR-13-1879. Epub 2013 Oct 18.

    PubMed 24141626

  • Zhang L, Yang J, Qian J, Li H, Romaguera JE, Kwak LW, Wang M, Yi Q. Role of the microenvironment in mantle cell lymphoma: IL-6 is an important survival factor for the tumor cells. Blood. 2012 Nov 1;120(18):3783-92. doi: 10.1182/blood-2012-04-424630. Epub 2012 Sep 11.

    PubMed 22968454

  • Balkwill F, Mantovani A. Inflammation and cancer: back to Virchow? Lancet. 2001 Feb 17;357(9255):539-45. doi: 10.1016/S0140-6736(00)04046-0.

    PubMed 11229684

  • Diakos CI, Charles KA, McMillan DC, Clarke SJ. Cancer-related inflammation and treatment effectiveness. Lancet Oncol. 2014 Oct;15(11):e493-503. doi: 10.1016/S1470-2045(14)70263-3.

    PubMed 25281468

  • Carbone A, Tripodo C, Carlo-Stella C, Santoro A, Gloghini A. The role of inflammation in lymphoma. Adv Exp Med Biol. 2014;816:315-33. doi: 10.1007/978-3-0348-0837-8_12.

    PubMed 24818728

  • Hogfeldt T, Bahnassy AA, Kwiecinska A, Osterborg A, Tamm KP, Porwit A, Zekri AR, Lundahl J, Khaled HM, Mellstedt H, Moshfegh A. Patients with activated B-cell like diffuse large B-cell lymphoma in high and low infectious disease areas have different inflammatory gene signatures. Leuk Lymphoma. 2013 May;54(5):996-1003. doi: 10.3109/10428194.2012.738365. Epub 2012 Nov 8.

    PubMed 23046110

  • Rotaru I, Gaman GD, Stanescu C, Gaman AM. Evaluation of parameters with potential prognosis impact in patients with primary gastric diffuse large B-cell lymphoma (PG-DLBCL). Rom J Morphol Embryol. 2014;55(1):15-21.

    PubMed 24715160

  • Eiro N, Vizoso FJ. Inflammation and cancer. World J Gastrointest Surg. 2012 Mar 27;4(3):62-72. doi: 10.4240/wjgs.v4.i3.62.

    PubMed 22530080

Questions about this trial

What is this clinical trial studying?

An observational study of B-cell Neoplasm, run by Assiut University at 1 site in Egypt.

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 15 inclusion and 2 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: opening soon, as of the sponsor's last update on 12 Mar 2025. 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 Egypt. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Marlien Wiliam Fayez, Resident doctor (01156900472, Marlienwilliam1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of Optimal Cut-off Values for Systemic Inflammatory Indices in B-cell Neoplasms Using Laboratory Blood Tests (time frame: Baseline). 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 NCT06847529, which also lists 14 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 12 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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