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

July 19, 2024 updated by: Shrouk Mostafa Galal, Sohag University

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: zeinab M kadry, lecturer
  • Phone Number: 01225960747

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
apparently healthy individuals with no chronic illness
Diagnostic test: real time pcr
evaluate the expression of certain circulating microRNAs by real time pcr
cases
newly diagnosed Non-Hodgkin's lymphoma patients
Diagnostic test: real time pcr
evaluate the expression of certain circulating microRNAs by real time pcr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microRNA16-1
Time Frame: 6 months
quantification of microRNA16-1 by real time PCR in Non-Hodgkin's lymphoma patients
6 months
microRNA 21
Time Frame: 6months
quantification of microRNA 21 by real time PCR in Non-Hodgkin's lymphoma patients
6months
microRNA 155
Time Frame: 6 months
quantification of microRNA155 by real time PCR in Non-Hodgkin's lymphoma patients
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

June 18, 2023

First Submitted That Met QC Criteria

June 18, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-06-03MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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