Value of MicroRNA30a in Philadelphia Positive Leukemic Patients

The Philadelphia chromosome in leukemogenesis:The truncated chromosome 22 that results from the reciprocal translocation t(9;22)(q34;q11) is known as (Ph) and is a hallmark of (CML). This aberrant fusion gene encodes the breakpoint cluster region-proto-(BCR-ABL1) oncogenic protein with persistently enhanced tyrosine kinase activity. Besides CML, the Ph is found in acute lymphoblastic leukemia, and mixed-phenotype acute leukemia.

Chronic myeloid leukemia is a myeloproliferative neoplasm, characterized by the unrestrained expansion of pluripotent bone marrow stem cells.The hallmark of the disease is the presence of a reciprocal t(9;22)(q34;q11.2), resulting in a derivative 9q+ and a small 22q-. The latter, known as the Philadelphia chromosome, results in a BCR-ABL fusion gene . The diagnosis requires fluorescent in situ hybridization (to demonstrate the BCR-ABL fusion gene or(PCR) to demonstrate the BCR-ABL mRNA transcript.

Study Overview

• Status: Not yet recruiting
• Conditions: Possibility of Using microRNA30a as a Prognostic Marker in Philadelphia Positive Leukemic Patients by Measure Level of microRNA30a in Blood Sample

Detailed Description

our study will discuss the possible value of microRNA30a as early predictor for TKIs resistance in newly diagnosed CML patients.

the study will dectect the possible value of microRNA30a as prognostic marker in Philadelphia positive acute leukemic patients(ALL, mixed-phenotype acute leukemia) on TKI therapy by assessment level of microRNA30a inpatients who achieved complete hematological remission(CHR) and who failed to achieve CHR.

The study goal has been taken through the role of microRNA30a in reducing ABL1 and BCR-ABL1 protein expression and microRNAs are capable of changing the levels of several key proteins at various steps of the autophagic pathway.

• Study Type: Observational
• Enrollment (Anticipated): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

70 patients diagnosed as Philadelphia positive leukemic patients(CML, acute lymphoblastic leukemia, and mixed-phenotype acute leukemia).

Description

3 a-Inclusion criteria

1_clinical diagnosis of Philadelphia positive leukemic patients (males and females).

2- Aged from 18- 60 years. 3-All eligible patients presenting at Clinical Haematology Unit Internal Medicine Department.

4- Without contraindication to receive TKIs therapy. 5-Must able to swallow tablet(TKI therapy).

-exclusion criteria

1. NO bone marrow aspirate and flow cytometry confirm their diagnosis.
2. patients who refuse to participate in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
2; Group of Philadelphia positive leukemic patients will included in the study who divide into: patient newly diagnosed CML treated with first line of tyrosine kinase inhibitors therapy.; Philadelphia positive acute leukemic patients(ALL, mixed-phenotype acute leukemia) on TKI therapy who achieved complete hematological remission(CHR) and who failed to achieve CHR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To detect the possibility of using microRNA30a as a prognostic marker in Philadelphia Positive Leukemic Patients by measure level of microRNA30a in blood sample of Philadelphia positive leukemic patients on tyrosine kinase inhibitor therapy	The study goal has been taken through the role of microRNA30a in reducing ABL1 and BCR-ABL1 protein expression and microRNAs are capable of changing the levels of several key proteins at various steps of the autophagic pathway.	2 years

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: July 10, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (ACTUAL): November 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AssiutU2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No