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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05921812
Collaborator
(none)
70
1
2
12
5.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: real time pcr
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Biochemical Role of Circulating microRNAs Expression as Diagnostic Markers for Non-Hodgkin's Lymphoma Patients
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control

apparently healthy individuals with no chronic illness

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

Active Comparator: cases

newly diagnosed Non-Hodgkin's lymphoma patients

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

Outcome Measures

Primary Outcome Measures

  1. microRNA16-1 [6 months]

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

  2. microRNA 21 [6months]

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

  3. microRNA 155 [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shrouk Mostafa Galal, demonstrator at medical biochemistry department, Sohag University
ClinicalTrials.gov Identifier:
NCT05921812
Other Study ID Numbers:
  • Soh-Med-23-06-03MS
First Posted:
Jun 27, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2023