Biochemical Role of Circulating microRNAs Expression as Diagnostic Markers for Non-Hodgkin's Lymphoma Patients

NCT05921812 | Recruiting

• 1 other identifier: Soh-Med-23-06-03MS
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Lymphomas are a fairly common malignancy accounting for approximately half of all newly diagnosed hematological neoplasms, and they comprise the sixth most common group of malignancies worldwide in both men and women, With marked geographic variations and affecting more males than females within the age range of 1 to 85 years but peaking within the second decades of life (Oluwasola AO et al., 2011, Roman E et al., 2011 and Jemal A et al., 2010) . Lymphomas have traditionally been classified as either Hodgkin's lymphoma (HL) or non-Hodgkin's lymphoma (NHL) based on the presence or absence of the Reed-Sternberg (RS) cell on histology. (Fitzmaurice C et al., 2017). Non-Hodgkin's lymphoma (NHLs) comprise a wide class of lymphoid neoplasms that evolve from the clonal expansion of mature B, T and natural killer (NK) cells in different stages of development (Morton, L.M. et al., 2014 and Schmitz R et al., 2009). NHLs are the most prevalent hematopoietic neoplasms, accounting for approximately 4.3% of all cancer diagnoses (Sant, M. et al., 2010) , Of them, B cell NHL accounts for approximately 30% of all lymphoid neoplasms, followed by HL (8%) and T/NK neoplasms (5%) (Morton, L.M. et al., 2006). MicroRNAs (miRNAs) are a class of small, naturally occurring, noncoding and single-stranded RNA molecules (18, 22 nucleotides) that function as post-transcriptional regulators by directly cleaving target messenger RNA (mRNA) or translational repression (Bartel DP. Et al., 2004). The discovery of miRNA has exposed a new layer of gene expression regulation that affects many physiological and pathological processes of life (Lawrie CH. Et al., 2013). Many abnormal miRNA expression patterns are found in various human malignancies, and certain miRNAs play roles as oncogenes or tumor suppressors (Ling N et al., 2013). Certain miRNAs have been found to characterize various subtypes of NHL and have important roles in B-cell differentiation and lymphomagenesis (Zhang J et al., 2009, Malumbres R et al., 2009, Basso K et al., 2009 and Auer RL et al., 2011). Recently, many studies had shown that tumor cell-specific miRNAs were detectable in the plasma and serum of patients with cancer. Therefore, miRNAs may be served as good biomarkers for early detection, diagnosis, and follow up of patients with cancer (Cortez MA et al., 2012).

Conditions

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (3)

• microRNA16-1

  quantification of microRNA16-1 by real time PCR in Non-Hodgkin's lymphoma patients

  6 months

• microRNA 21

  quantification of microRNA 21 by real time PCR in Non-Hodgkin's lymphoma patients

  6months

• microRNA 155

  quantification of microRNA155 by real time PCR in Non-Hodgkin's lymphoma patients

  6 months

Study Arms (2)

control

apparently healthy individuals with no chronic illness

Diagnostic Test: real time pcr

cases

newly diagnosed Non-Hodgkin's lymphoma patients

Diagnostic Test: real time pcr

Interventions

real time pcr DIAGNOSTIC_TEST

evaluate the expression of certain circulating microRNAs by real time pcr

cases; control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have newly diagnosed, histo-pathologically proved Non-Hodgkin's lymphoma,aged from 18-75 and healthy control of matched age and sex

You may qualify if:

• This study will include patients who have newly diagnosed, histo-pathologically proved Non-Hodgkin's lymphoma.
• Age from 18 to 75 years old.
• anti-neoplastic treatment naïve patients.
• No associated other malignancies (neither Synchronous nor metachronous) than Non-Hodgkin's lymphoma.

You may not qualify if:

• children below 18 years old or elderly people more than 75 years old
• patients not newly diagnosed with non-Hodgkin's lymphoma
• presence of any associated other malignancies than non-Hodgkin's lymphoma

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Egypt

RECRUITING

Related Publications (4)

• Sun CM, Luan CF. Overexpression of microRNA-21 in peripheral blood mononuclear cells of patients with B-cell non-Hodgkin's lymphoma is associated with disease stage and treatment outcome. Eur Rev Med Pharmacol Sci. 2015 Sep;19(18):3397-402.

  PMID: 26439034 BACKGROUND

• Jorgensen S, Paulsen IW, Hansen JW, Tholstrup D, Hother C, Sorensen E, Petersen MS, Nielsen KR, Rostgaard K, Larsen MAH, Brown PN, Ralfkiaer E, Homburg KM, Hjalgrim H, Erikstrup C, Ullum H, Troelsen J, Gronbaek K, Pedersen OB. The value of circulating microRNAs for early diagnosis of B-cell lymphoma: A case-control study on historical samples. Sci Rep. 2020 Jun 15;10(1):9637. doi: 10.1038/s41598-020-66062-1.

  PMID: 32541886 BACKGROUND

• Bedewy AML, Elmaghraby SM, Shehata AA, Kandil NS. Prognostic Value of miRNA-155 Expression in B-Cell Non-Hodgkin Lymphoma. Turk J Haematol. 2017 Aug 2;34(3):207-212. doi: 10.4274/tjh.2016.0286. Epub 2017 Feb 1.

  PMID: 28148469 BACKGROUND

• Fang C, Zhu DX, Dong HJ, Zhou ZJ, Wang YH, Liu L, Fan L, Miao KR, Liu P, Xu W, Li JY. Serum microRNAs are promising novel biomarkers for diffuse large B cell lymphoma. Ann Hematol. 2012 Apr;91(4):553-9. doi: 10.1007/s00277-011-1350-9. Epub 2011 Oct 11.

  PMID: 21987025 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

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

Central Study Contacts

shrouk M Galal, demonstrator

CONTACT

01117449592; shroukmostafa@med.sohag.edu.eg

zeinab M kadry, lecturer

CONTACT

01225960747

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator at medical biochemistry department

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 27, 2023
• Study Start: February 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: March 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

EG (1)