Biochemical Role of Circulating microRNAs Expression as Diagnostic Markers for Non-Hodgkin's Lymphoma Patients
Primary Purpose
Non-Hodgkin Lymphoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
real time pcr
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Hodgkin Lymphoma
Eligibility Criteria
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
Sites / Locations
- Sohag University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
control
cases
Arm Description
apparently healthy individuals with no chronic illness
newly diagnosed Non-Hodgkin's lymphoma patients
Outcomes
Primary Outcome Measures
microRNA16-1
quantification of microRNA16-1 by real time PCR in Non-Hodgkin's lymphoma patients
microRNA 21
quantification of microRNA 21 by real time PCR in Non-Hodgkin's lymphoma patients
microRNA 155
quantification of microRNA155 by real time PCR in Non-Hodgkin's lymphoma patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05921812
Brief Title
Biochemical Role of Circulating microRNAs Expression as Diagnostic Markers for Non-Hodgkin's Lymphoma Patients
Official Title
Biochemical Role of Circulating microRNAs Expression as Diagnostic Markers for Non-Hodgkin's Lymphoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
apparently healthy individuals with no chronic illness
Arm Title
cases
Arm Type
Active Comparator
Arm Description
newly diagnosed Non-Hodgkin's lymphoma patients
Intervention Type
Diagnostic Test
Intervention Name(s)
real time pcr
Intervention Description
evaluate the expression of certain circulating microRNAs by real time pcr
Primary Outcome Measure Information:
Title
microRNA16-1
Description
quantification of microRNA16-1 by real time PCR in Non-Hodgkin's lymphoma patients
Time Frame
6 months
Title
microRNA 21
Description
quantification of microRNA 21 by real time PCR in Non-Hodgkin's lymphoma patients
Time Frame
6months
Title
microRNA 155
Description
quantification of microRNA155 by real time PCR in Non-Hodgkin's lymphoma patients
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shrouk M Galal, demonstrator
Phone
01117449592
Email
shroukmostafa@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
zeinab M kadry, lecturer
Phone
01225960747
Facility Information:
Facility Name
Sohag University
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, Professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
26439034
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.
Results Reference
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PubMed Identifier
32541886
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.
Results Reference
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PubMed Identifier
28148469
Citation
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.
Results Reference
background
PubMed Identifier
21987025
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.
Results Reference
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Biochemical Role of Circulating microRNAs Expression as Diagnostic Markers for Non-Hodgkin's Lymphoma Patients
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