NCT04312607

Brief Summary

Evaluate diagnostic and prognostic value of CD26 positive stem cell Stem Cells in classic myeloproliferative neoplasms (MPNs). To study CD26 expression on different phases of CML (chronic phase, accelerated phase, blastic phase). To investigate whether CD26 positive stem cell are expressed only in Philadelphia chromosome positive MPN (CML) and/or in Philadelphia chromosome negative MPN (PV, ET, PMF).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 16, 2020

Last Update Submit

March 16, 2020

Conditions

Myeloproliferative Neoplasm

Outcome Measures

Primary Outcomes (1)

  • diagnostic value

    diagnostic value of CD 26 in MPNs

    within 4 months from study start

Secondary Outcomes (1)

  • prognostic value

    6 month after start of study

Study Arms (2)

Philadelphia chromosome positive

according to PCR detection of BCR-ABL gene CD26 expression on stem cells

Diagnostic Test: BCR-ABL gene PCR

Philadelphia chromosome negative

according to PCR detection of BCR-ABL gene CD26 expression on stem cells

Diagnostic Test: BCR-ABL gene PCR

Interventions

BCR-ABL gene PCRDIAGNOSTIC_TEST

peripheral blood sampling for detection of Philadelphia chromosome and flowcytometry for detection of CD26 positive stem cells

Also known as: flowcytometry for CD26 positive stem cells
Philadelphia chromosome negativePhiladelphia chromosome positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients newly diagnosed one of MPNs for further investigations by PCR for Philadelphia chromosome and flowcytometry for CD26 positve stem cells

You may qualify if:

  • Patients diagnosed one of classic MPNs (CML, PV, ET, PMF).

You may not qualify if:

  • Patients below 18 years.
  • Pregnancy.
  • Any associated Solid or hematopoietic neoplasm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Levine RL, Pardanani A, Tefferi A, Gilliland DG. Role of JAK2 in the pathogenesis and therapy of myeloproliferative disorders. Nat Rev Cancer. 2007 Sep;7(9):673-83. doi: 10.1038/nrc2210.

    PMID: 17721432BACKGROUND

  • Thapa B, Fazal S, Parsi M, Rogers HJ. Myeloproliferative Neoplasms. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK531464/

    PMID: 30285359BACKGROUND

  • Jabbour E, Kantarjian H. Chronic myeloid leukemia: 2016 update on diagnosis, therapy, and monitoring. Am J Hematol. 2016 Feb;91(2):252-65. doi: 10.1002/ajh.24275.

    PMID: 26799612BACKGROUND

  • Raspadori D, Pacelli P, Sicuranza A, Abruzzese E, Iurlo A, Cattaneo D, Gozzini A, Galimberti S, Barate C, Pregno P, Nicolosi M, Sora F, Annunziata M, Luciano L, Caocci G, Moretti S, Sgherza N, Fozza C, Russo S, Usala E, Liberati MA, Ciofini S, Trawinska MM, Gozzetti A, Bocchia M. Flow Cytometry Assessment of CD26+ Leukemic Stem Cells in Peripheral Blood: A Simple and Rapid New Diagnostic Tool for Chronic Myeloid Leukemia. Cytometry B Clin Cytom. 2019 Jul;96(4):294-299. doi: 10.1002/cyto.b.21764. Epub 2019 Feb 3.

    PMID: 30714299BACKGROUND

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • doha M ali, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

doha M ali, MD

CONTACT

01096100320dmadody90@gmail.com

Effat AH Tony, prof

CONTACT

01097330309effattony@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Value of CD26 positive stem cell marker in patients with classical myeloproliferative neoplasms

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 18, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2021

Study Completion

March 1, 2022

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share