Carotid Plaque Burden in Patients With Philadelphia Negative Myeloproliferative Neoplasms

Neutrophil-Lymphocyte Ratio and Carotid Plaque Burden in Patients With Philadelphia Negative Myeloproliferative Neoplasms and Their Relation to JAK2V617F Mutation

In around 90% of the patients with MPNs, an acquired mutation that promotes JAK/STAT signaling is identified [3, 4]. The JAK/STAT pathway transduces signals from cytokines including erythropoietin, thrombopoietin, and granulocyte colony-stimulating factor.24 A point mutation that activates JAK2, JAK2V617F, is present in around 95% of patients with PV and 40% to 60% of patients with ET and MF

Study Overview

• Status: Recruiting
• Conditions: Myeloproliferative Neoplasm

Detailed Description

All patients will be subjected to a thorough assessment of history, complete clinical examination, and investigations as complete blood picture including neutrophil-lymphocyte ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum creatinine and lipid profile. All patients will undergo carotid imaging using Colour Doppler ultrasonography for assessment of carotid plaque burden.

The control group will undergo carotid ultrasonography who will be recruited among apparently healthy volunteers aiming to match the patient group regarding age, sex and classical risk factors for atherosclerosis as arterial hypertension, hyperlipidemia, diabetes, smoking or obesity.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mahmoud Gaber, dr; Phone Number: +201007399833; Email: mahmoudgaber@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Faculty of medicine
    • Contact: Mahmoud Gaber; Phone Number: +201007399833; Email: mahmoudgaber@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients with Philadelphia negative myeloproliferative neoplasms who were diagnosed according to the WHO 2016 criteria, at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic.

Description

Inclusion Criteria:

• All patients aged 18 years and older who were newly diagnosed to have Philadelphia negative myeloproliferative neoplasms between September 2014 and November 2022 at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic.

Exclusion Criteria:

• Patients were excluded if: (1) their disease of thrombocytosis or polycythemia was determined to be reactive, (2) their disease was not newly diagnosed, (3) their disease met WHO criteria for chronic or acute myeloid leukemia.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil-Lymphocyte Ratio in Patients with Philadelphia Negative Myeloproliferative Neoplasms	All patients will be subjected to a thorough assessment of history, complete clinical examination, and investigations as complete blood picture including neutrophil-lymphocyte ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum creatinine and lipid profile.	baseline
Carotid Plaque Burden in Patients with Philadelphia Negative Myeloproliferative Neoplasms	All patients will undergo carotid imaging using Colour Doppler ultrasonography for assessment of carotid plaque burden. Extracranial carotid arteries were divided into three sectors on each side: common carotid artery and its bulb, internal carotid artery, and external carotid artery. At least one plaque in any sector was scored 1 point, while the absence of plaques was scored 0. Thus, the carotid plaque score ranged from 0 (absence of plaques) to 6 (plaques in all sectors)	baseline

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Mahmoud Gaber, Sohag University

Publications and helpful links

General Publications

• Kralovics R, Passamonti F, Buser AS, Teo SS, Tiedt R, Passweg JR, Tichelli A, Cazzola M, Skoda RC. A gain-of-function mutation of JAK2 in myeloproliferative disorders. N Engl J Med. 2005 Apr 28;352(17):1779-90. doi: 10.1056/NEJMoa051113.
• Accorsi F. Color Doppler of the extracranial and intracranial arteries in the acute phase of cerebral ischemia. J Ultrasound. 2013 Sep 21;16(4):187-93. doi: 10.1007/s40477-013-0036-7. eCollection 2013 Sep 21.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Neoplasms; Myeloproliferative Disorders
• Other Study ID Numbers: Carotid Doppler in MPNs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No