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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05943093
Other study ID # PCR in acute leukemia
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2023
Est. completion date August 2025

Study information

Verified date July 2023
Source Assiut University
Contact Fatma Refaat Ibrahim
Phone 01032073035
Email drfatmarefaat@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- Study the expression level of H19 gene in the samples from ALL patients by real-time PCR. - Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients.


Description:

Acute lymphoblastic leukemia (ALL) is the most common cancer affecting children and adolescents (Zeng XL et al, 2023). ALL is a haematological malignancy characterized by the malignant clonal expansion of lymphoid hematopoietic precursors (Hong Z et al, 2021). It arises from B- or T-lineage lymphoid progenitors: B-cell-precursor ALL (B-ALL) and T-cell ALL (T-ALL) (Brady SW et al., 2022). Rrelapse in ALL is the fundamental cause of treatment failure in 15-20% of patients (Hulleman E et al, 2009). Therefore, the exploration of novel functional molecules that play a role in ALL pathogenesis could be effective therapeutic targets for this disease (Asadi M et al, 2023). Long non-coding RNAs (lncRNAs) are non-protein coding transcripts longer than 200 nucleotides (Kopp F et al, 2018). H19 was the first lncRNA to be discovered and submitted for genomic imprinting (Yoshimura H et al, 2018). It has a role in embryogenesis and tumorigenesis (Yoshimura H et al, 2014). It also has an indispensable role in enhancing cell proliferation, differentiation, migration, invasion, and chemo resistance (Li Y et al, 2020). Recent evidence has shown that H19 is an oncogene and is overexpressed in breast, liver, endometrial, lung, cervical, and esophageal cancers (Asadi M et al, 2023). A similar pattern of H19 expression was observed in various types of leukemias, including chronic myeloid leukemia (CML) (Morlando M et al, 2015) and acute myeloid leukemia (AML) (Zhang Tj et al, 2018).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 96
Est. completion date August 2025
Est. primary completion date July 2025
Accepts healthy volunteers
Gender All
Age group 2 Months to 70 Years
Eligibility Inclusion Criteria: - Newly diagnosed ALL patients. Exclusion Criteria: - 1-Presence of other haematological disorders, history of other malignancies or relapsed ALL. 2-Patients under chemotherapy or radiotherapy.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary - Study the expression level of H19 gene in the samples from ALL patients by real-time PCR. baseline
Secondary Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients. baseline
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