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

Study Overview
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Brief Summary
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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).

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

Conditions
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Non-Hodgkin Lymphoma

Intervention / Treatment
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* Diagnostic Test: real time pcr


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>apparently healthy individuals with no chronic illness | Diagnostic Test: real time pcr<br>* evaluate the expression of certain circulating microRNAs by real time pcr<br>|
| Active Comparator: cases<br>newly diagnosed Non-Hodgkin's lymphoma patients | Diagnostic Test: real time pcr<br>* evaluate the expression of certain circulating microRNAs by real time pcr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |