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ITGA4 Gene Methylation Status in Chronic Lymphocytic Leukemia

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05371392
Collaborator
(none)
80
Enrollment
15
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Chronic lymphocytic leukemia (CLL) is a clonal lymphoproliferative disorder that is characterized by heterogeneous presentation at the clinical and molecular levels. ITGA4 protein has been found to be deregulated in CLL with adverse clinical outcome. ITGA4 gene (CD49d) encodes a member of the integrin alpha chain family of proteins and is considered a negative prognosticator in CLL with aggressive course and short time to treatment.

The aim of the study:

is to investigate ITGA4 gene expression pattern and to explore its methylation heterogeneity in CLL.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    ITGA4 Gene Methylation Status in Chronic Lymphocytic Leukemia
    Anticipated Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    patient group
    control group

    Outcome Measures

    Primary Outcome Measures

    1. ITGA4 gene expression pattern and its methylation heterogeneity in chronic lymphocytic leukemia [1 year following the startpoint of the study]

      Detection of ITGA4 gene expression and ITGA4 gene methylation in blood samples in patients with chronic lymphocytic leukemia, Briefly, total RNA and genomic DNA extraction from fresh peripheral blood samples by Real-time -RT-polymerase chain reaction system (RT-PCR) will be carried out. Rate of ITGA4 gene expression and its methylation will be recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with newly diagnosed CLL.
    Exclusion Criteria:

    • ▪ Patients previously diagnosed as CLL and received treatment before.

    • Patients with other solid tumors.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amer Ahmed Youssef Abdalkareem, Specialist of clinical and chemical pathology, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05371392
    Other Study ID Numbers:
    • soh-med-22-04-21
    First Posted:
    May 12, 2022
    Last Update Posted:
    May 12, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of May 12, 2022