"Peripheral Blood Dipeptidylpeptidase IV (CD26) Positive Leukemic Stem Cells in Chronic Myeloid Leukemia as a Diagnostic Marker"

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05543161
Collaborator
(none)
50
1
12
4.2

Study Details

Study Description

Brief Summary

Chronic myeloid leukemia (CML) is a stem cell (SC) neoplasm which originates from an incomplete process of differentiation of the hematopoietic stem cells (HSCs) to the adult cells which lead to accumulation of their immature form into the BM and the peripheral blood. It is characterized by the reciprocal translocation. The resulting oncoprotein, BCR/ABL1, is considered essential for the initiation and manifestation of the disease . In CML, leukemic stem cell (LSC) supposedly resides within the CD45+/ CD34+/CD38-/Lin- fraction of the leukemic clone (3). However, normal hematopoietic SC also exhibit this phenotype so that additional markers are required to discriminate CML LSC from normal SC. CD34+/CD38-/Lin- CML LSC specifically co-express dipeptidylpeptidase IV(DPPIV=CD26). This enzyme disrupts LSC-niche interactions by degrading stroma derived factor-1 (SDF-1). Moreover, CD26 is a robust biomarker for the quantification and isolation of CML LSC (4). It was reported that CD26+ LSCs were significantly correlated with BCR-ABL1 transcript level at diagnosis and after three months of treatment with tyrosine kinase inhibitor (TKI) .

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    "Peripheral Blood Dipeptidylpeptidase IV (CD26) Positive Leukemic Stem Cells in Chronic Myeloid Leukemia as a Diagnostic Marker"
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Peripheral Blood Dipeptidylpeptidase IV (CD26) [1 year]

      to detect CD26+ LSCs by flow cytometry for accurate diagnosis of CML patients from peripheral blood sample to reduce the need for Bone Marrow aspiration.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • : All suspected patients for CML diagnosis aged more than 18 years who presented with high white blood cells(WBCs) count , marked shift to left in peripheral blood with or without splenomegaly .
    Exclusion Criteria:
    • Patients on treatment or presence of blasts in peripheral blood sample.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Hospital Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    • Principal Investigator: Eid, Sohag univerisity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rowaida Moahmed Mohamed, Clinical pathology specialist , Sohag general hospital, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05543161
    Other Study ID Numbers:
    • Soh-Med-22-09-10
    First Posted:
    Sep 16, 2022
    Last Update Posted:
    Sep 16, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 16, 2022