Carotid Plaque Burden in Patients With Philadelphia Negative Myeloproliferative Neoplasms

Recruiting

• Conditions: Myeloproliferative Neoplasm

• Registration Number: NCT05993052
• Lead Sponsor: Sohag University

Brief Summary

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

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 Timeline

• Study Start: 2022-12-15
• Status Verified: 2023-08
• Primary Completion: 2023-08
• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-14
• Last Update Submitted: 2023-08-14
• Study First Posted: 2023-08-15
• Last Update Posted: 2023-08-15
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neutrophil-Lymphocyte Ratio in Patients with Philadelphia Negative Myeloproliferative Neoplasms	baseline	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.
Carotid Plaque Burden in Patients with Philadelphia Negative Myeloproliferative Neoplasms	baseline	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)

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Sohag, Egypt