Study of miRNA-155 in Acute Leukemia

March 30, 2023 updated by: Noura Farouk Abdallah, Sohag University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elham o Hamed, professor

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of miRNA-155
Time Frame: one year
Detection of miRNA-155 using real time PCR on bone marrow aspirate samples
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-03-01MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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