Systemic Inflammatory Markers in B-cell Neoplasm

NCT06847529 | Not Yet Recruiting

• 1 other identifier: markers In B-cell tumors
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

B-cell Neoplasm

Keywords

Systemic inflammatory markers as a prognostic index

Outcome Measures

Primary Outcomes (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.

  Baseline

Secondary Outcomes (1)

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

  From baseline up to 8 months

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

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

You may qualify if:

• 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)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (14)

• 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.

  PMID: 24154716 BACKGROUND

• 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.

  PMID: 26712690 BACKGROUND

• 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.

  PMID: 26710772 BACKGROUND

• 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.

  PMID: 25604508 BACKGROUND

• 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.

  PMID: 23659971 BACKGROUND

• 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.

  PMID: 25733167 BACKGROUND

• 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.

  PMID: 24141626 BACKGROUND

• 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.

  PMID: 22968454 BACKGROUND

• 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.

  PMID: 11229684 BACKGROUND

• 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.

  PMID: 25281468 BACKGROUND

• 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.

  PMID: 24818728 BACKGROUND

• 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.

  PMID: 23046110 BACKGROUND

• 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.

  PMID: 24715160 BACKGROUND

• 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.

  PMID: 22530080 BACKGROUND

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alaa El-Din Abdel Moneim El-Sayed, Doctor

  Assiut University

  STUDY CHAIR

Central Study Contacts

Marlien Wiliam Fayez, Resident doctor

CONTACT

01156900472; Marlienwilliam1@gmail.com

Mai Mostafa Mohamed, Doctor

CONTACT

01223971678; Mai_heamatology@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: March 22, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)