Study of miRNA-155 in Acute Leukemia

NCT05809050 | Unknown

• 1 other identifier: Soh-Med-23-03-01MD
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• Detection of miRNA-155

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

  one year

Study Arms (2)

control group

represents the control group ( ITP cases

Diagnostic Test: BM aspirate

AL group

cases of AcuteLeukemia.

Diagnostic Test: BM aspirate

Interventions

BM aspirate DIAGNOSTIC_TEST

Bone Marrow aspiration \& Examination

AL group; control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group (I): represents the control group ( ITP cases). Group (II): represents the cases of Acute Leukemia.

You may qualify if:

• approval to sign an informed written consent, patient with newly diagnosed AL.

You may not qualify if:

• Refusal to sign an informed written consent, Cases with Chronic leukemias, Lymphoma or Leukemic phase of lymphoma or patients on chemotherapy.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (4)

• Kirtonia A, Pandya G, Sethi G, Pandey AK, Das BC, Garg M. A comprehensive review of genetic alterations and molecular targeted therapies for the implementation of personalized medicine in acute myeloid leukemia. J Mol Med (Berl). 2020 Aug;98(8):1069-1091. doi: 10.1007/s00109-020-01944-5. Epub 2020 Jul 3.

  PMID: 32620999 BACKGROUND

• Culp-Hill R, D'Alessandro A, Pietras EM. Extinguishing the Embers: Targeting AML Metabolism. Trends Mol Med. 2021 Apr;27(4):332-344. doi: 10.1016/j.molmed.2020.10.001. Epub 2020 Oct 26.

  PMID: 33121874 BACKGROUND

• Dachi RA, Mustapha FG, Mahdi M, Abbas H. Acute Leukaemias in Bauchi State, Northeastern Nigeria: Pattern of Presentations and Clinical Entities. West Afr J Med. 2022 May 27;39(5):497-500.

  PMID: 35633629 BACKGROUND

• Lefeivre T, Jones L, Trinquand A, Pinton A, Macintyre E, Laurenti E, Bond J. Immature acute leukaemias: lessons from the haematopoietic roadmap. FEBS J. 2022 Aug;289(15):4355-4370. doi: 10.1111/febs.16030. Epub 2021 Jun 10.

  PMID: 34028982 BACKGROUND

Central Study Contacts

Noura F Abdullah, specialist

CONTACT

01005360731; noura.rashwan@med.sohag.edu.eg

Elham o Hamed, professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pathology specialist at sohag university

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-03