NCT05477667

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 26, 2022

Last Update Submit

July 26, 2022

Conditions

Non Hodgkin Lymphoma and Acute Leukemia

Outcome Measures

Primary Outcomes (2)

  • MiRNA-124 level

    Detection of expressin level of MiRNA-124 IN Non-Hodgkin's Lymphoma and acute leukemia

    6 months

  • let-7a level

    Detection of expressin level of let-7a IN Non-Hodgkin's Lymphoma and acute leukemia

    6 months

Study Arms (3)

control group

ACTIVE COMPARATOR

the patients with non-malignant hematological diseases

Diagnostic Test: real time pcr

the cases (A)

ACTIVE COMPARATOR

NHL .

Diagnostic Test: real time pcr

the cases (B)

ACTIVE COMPARATOR

acute leukemia

Diagnostic Test: real time pcr

Interventions

real time pcrDIAGNOSTIC_TEST

Detection of expressin level of MiRNA-124 and let-7a using real time pcr

control groupthe cases (A)the cases (B)

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • approval to sign an informed written consent,
  • patient with NHL and acute leukemia .

You may not qualify if:

  • Refusal to sign an informed written consent,
  • patient on chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 28153383BACKGROUND

  • 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.

    PMID: 28148469BACKGROUND

  • 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.

    PMID: 30207593BACKGROUND

  • 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.

    PMID: 32888820BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

sara t mahmoud, assisstent professor

CONTACT

01024914157sara.ahmed@med.sohag.edu.eg

rania M bakry, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstent professor at clinical pathology department at faculty of medicine sohag university hospital

Study Record Dates

First Submitted

July 26, 2022

First Posted

July 28, 2022

Study Start

October 1, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations

EG(1)