Study of miRNA-155 in Acute Leukemia

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05809050
Collaborator
(none)
50
12

Study Details

Study Description

Brief Summary

The leukaemias are a heterogeneous group of blood cancers, Acute leukaemia (AL) is caused by malignant proliferation of blood cells arrested at an immature stage of development, They are very aggressive diseases that run a rapidly fatal course if not promptly diagnosed and appropriately treated. Misdiagnosis is very common with delay in diagnosis and prompt treatment being the causes of high morbidity and mortality in acute leukaemias.

Although with the continuous improvement of clinical and laboratory diagnosis and treatment methods, the prognosis of AML has been significantly improved, but there are still about 70% of patients who cannot survive more than 5 years after diagnosis The activity of miRNAs in tumors is regulated by the same alterations affecting protein-coding genes, such as chromosomal rearrangements, genomic amplifications or deletions or mutations, abnormal transcriptional control, dysregulation of epigenetic changes and defects in the biogenesis machinery A typical chromosomal rearrangement is a chromosomal translocation, especially in hematological malignancies, in which it promotes tumor development and progression by the promoter exchange or by the creation of chimeric genes translated as fusion proteins. In Acute Myeloid Leukemia (AML) patients with myeloid/lymphoid leukemia gene (or mixed-lineage leukemia, MLL) rearrangement, by large-scale genome-wide microarray analysis, it was demonstrated that among 48 selected miRNAs, 47 of them are increased

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: BM aspirate

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Study of miRNA-155 in Acute Leukemia
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
control group

represents the control group ( ITP cases

Diagnostic Test: BM aspirate
Bone Marrow aspiration & Examination

AL group

cases of AcuteLeukemia.

Diagnostic Test: BM aspirate
Bone Marrow aspiration & Examination

Outcome Measures

Primary Outcome Measures

  1. Detection of miRNA-155 [one year]

    Detection of miRNA-155 using real time PCR on bone marrow aspirate samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • approval to sign an informed written consent, patient with newly diagnosed AL.
Exclusion Criteria:
  • Refusal to sign an informed written consent, Cases with Chronic leukemias, Lymphoma or Leukemic phase of lymphoma or patients on chemotherapy.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Noura Farouk Abdallah, clinical pathology specialist at sohag university, Sohag University
ClinicalTrials.gov Identifier:
NCT05809050
Other Study ID Numbers:
  • Soh-Med-23-03-01MD
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 12, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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 Apr 12, 2023