Clinical trial NCT05543161: "Peripheral Blood Dipeptidylpeptidase IV (CD26) Positive Leukemic Stem Cells in Chronic Myeloid Leukemia as a Diagnostic Marker"
Official title: "Peripheral Blood Dipeptidylpeptidase IV (CD26) Positive Leukemic Stem Cells in Chronic Myeloid Leukemia as a Diagnostic Marker"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Myeloid Leukemia, Chronic Phase
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 .

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) .


Eligibility criteria: 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.

Primary outcomes:
measure: Peripheral Blood Dipeptidylpeptidase IV (CD26)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
affiliation: Sohag univerisity
name: Eid
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lane SW, Scadden DT, Gilliland DG. The leukemic stem cell niche: current concepts and therapeutic opportunities. Blood. 2009 Aug 6;114(6):1150-7. doi: 10.1182/blood-2009-01-202606. Epub 2009 Apr 28.
citation: Ebian HF, Abdelnabi AM, Abdelazem AS, Khamis T, Fawzy HM, Hussein S. Peripheral blood CD26 positive leukemic stem cells as a possible diagnostic and prognostic marker in chronic myeloid leukemia. Leuk Res Rep. 2022 May 9;17:100321. doi: 10.1016/j.lrr.2022.100321. eCollection 2022.
citation: Waumans Y, Baerts L, Kehoe K, Lambeir AM, De Meester I. The Dipeptidyl Peptidase Family, Prolyl Oligopeptidase, and Prolyl Carboxypeptidase in the Immune System and Inflammatory Disease, Including Atherosclerosis. Front Immunol. 2015 Aug 7;6:387. doi: 10.3389/fimmu.2015.00387. eCollection 2015.
citation: Lee SA, Kim YR, Yang EJ, Kwon EJ, Kim SH, Kang SH, Park DB, Oh BC, Kim J, Heo ST, Koh G, Lee DH. CD26/DPP4 levels in peripheral blood and T cells in patients with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Jun;98(6):2553-61. doi: 10.1210/jc.2012-4288. Epub 2013 Mar 28.