Back to resultsStudy of Let-7a and miRNA-124 in Cases of Non-Hodgkin's Lymphoma and Acute Leukemia
Primary Purpose
Non Hodgkin Lymphoma and Acute Leukemia
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 and Acute Leukemia
Eligibility Criteria
Inclusion Criteria:
- approval to sign an informed written consent,
- patient with NHL and acute leukemia .
Exclusion Criteria:
- Refusal to sign an informed written consent,
- patient on chemotherapy
Sites / Locations
- Sohag University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
control group
the cases (A)
the cases (B)
Arm Description
the patients with non-malignant hematological diseases
NHL .
acute leukemia
Outcomes
Primary Outcome Measures
MiRNA-124 level
Detection of expressin level of MiRNA-124 IN Non-Hodgkin's Lymphoma and acute leukemia
let-7a level
Detection of expressin level of let-7a IN Non-Hodgkin's Lymphoma and acute leukemia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05477667
Brief Title
Study of Let-7a and miRNA-124 in Cases of Non-Hodgkin's Lymphoma and Acute Leukemia
Official Title
Study of Let-7a and miRNA-124 in Cases of Non-Hodgkin's Lymphoma and Acute Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (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
MiRNAs are noncoding RNAs (ncRNAs) that drive post-transcriptional negative regulation of gene expression by promoting the degradation or translational blockade of their target mRNAs. MiRNAs are 21-24-nucleotide-long RNA molecules that are processed from longer RNA precursors (pri-miRNAs) , and either the 5' or the 3' strand of the mature miRNA duplex is loaded into the Argonaute (AGO) family of proteins to form a miRNA-induced silencing complex (miRISC) When bound to AGO proteins, mature miRNAs destabilize or inhibit the translation of partially complementary target mRNAsMiRNA-124 has been shown to be a tumor suppressor, and a decrease in its expression level is typical of tumors of various localization, but there is no evidence of the role of miRNA-124 in the development of NHL . There are a number of studies reflecting the involvement of miRNA-124 in hematopoiesis. Liu et al. showed that miRNA-124 regulates Tip110 that is involved in the differentiation of hematopoietic stem cellsThe let-7 family has been shown to influence the pathogenesis of a variety of hematological malignancies through the changing expression of a number of oncogenic pathways, particularly those related with MYC and that might affect hematopoietic carcinogenesis through the modulation of inflammatory pathways
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma and Acute Leukemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
the patients with non-malignant hematological diseases
Arm Title
the cases (A)
Arm Type
Active Comparator
Arm Description
NHL .
Arm Title
the cases (B)
Arm Type
Active Comparator
Arm Description
acute leukemia
Intervention Type
Diagnostic Test
Intervention Name(s)
real time pcr
Intervention Description
Detection of expressin level of MiRNA-124 and let-7a using real time pcr
Primary Outcome Measure Information:
Title
MiRNA-124 level
Description
Detection of expressin level of MiRNA-124 IN Non-Hodgkin's Lymphoma and acute leukemia
Time Frame
6 months
Title
let-7a level
Description
Detection of expressin level of let-7a IN Non-Hodgkin's Lymphoma and acute leukemia
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
approval to sign an informed written consent,
patient with NHL and acute leukemia .
Exclusion Criteria:
Refusal to sign an informed written consent,
patient on chemotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sara t mahmoud, assisstent professor
Phone
01024914157
Email
sara.ahmed@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
rania M bakry, professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elshrif, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28153383
Citation
Armitage JO, Gascoyne RD, Lunning MA, Cavalli F. Non-Hodgkin lymphoma. Lancet. 2017 Jul 15;390(10091):298-310. doi: 10.1016/S0140-6736(16)32407-2. Epub 2017 Jan 31.
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
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PubMed Identifier
30207593
Citation
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.
Results Reference
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PubMed Identifier
32888820
Citation
Fuertes T, Ramiro AR, de Yebenes VG. miRNA-Based Therapies in B Cell Non-Hodgkin Lymphoma. Trends Immunol. 2020 Oct;41(10):932-947. doi: 10.1016/j.it.2020.08.006. Epub 2020 Sep 1.
Results Reference
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Study of Let-7a and miRNA-124 in Cases of Non-Hodgkin's Lymphoma and Acute Leukemia
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