Study of miRNA-155 in Acute Leukemia

Acute Leukemia Clinical Trial

Official title:

Study of miRNA-155 in Acute Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05809050
• Other study ID #: Soh-Med-23-03-01MD
• Status: Not yet recruiting
• Start date: April 2023
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Sohag University
• Contact: Noura F Abdullah, specialist
• Phone: 01005360731
• Email: noura.rashwan[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

Diagnostic Test:
• BM aspirate
Bone Marrow aspiration & Examination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of miRNA-155	Detection of miRNA-155 using real time PCR on bone marrow aspirate samples	one year