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

Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05921812
• Other study ID #: Soh-Med-23-06-03MS
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: Sohag University
• Contact: shrouk M Galal, demonstrator
• Phone: 01117449592
• Email: shroukmostafa[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 1, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. This study will include patients who have newly diagnosed, histo-pathologically proved Non-Hodgkin's lymphoma.

2. Age from 18 to 75 years old.

3. anti-neoplastic treatment naïve patients.

4. No associated other malignancies (neither Synchronous nor metachronous) than Non-Hodgkin's lymphoma.

Exclusion Criteria:

1. children below 18 years old or elderly people more than 75 years old

2. patients not newly diagnosed with non-Hodgkin's lymphoma

3. presence of any associated other malignancies than non-Hodgkin's lymphoma

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Diagnostic Test:
• real time pcr
evaluate the expression of certain circulating microRNAs by real time pcr

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microRNA16-1	quantification of microRNA16-1 by real time PCR in Non-Hodgkin's lymphoma patients	6 months
Primary	microRNA 21	quantification of microRNA 21 by real time PCR in Non-Hodgkin's lymphoma patients	6months
Primary	microRNA 155	quantification of microRNA155 by real time PCR in Non-Hodgkin's lymphoma patients	6 months